← Product Code [HRX](/productcode/HRX) · K970642

# TENOSCOPE (K970642)

_Luxtec Corp. · HRX · May 21, 1997 · Orthopedic · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K970642

## Device Facts

- **Applicant:** Luxtec Corp.
- **Product Code:** [HRX](/productcode/HRX.md)
- **Decision Date:** May 21, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.1100
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Indications for Use

The TenoScope is indicated for the visualization and diagnosis of a severed tendon which has retracted within its sheath and cannot be retrieved by non-invasive maneuvers.

## Device Story

TenoScope is a visualization device used by surgeons to locate and diagnose retracted severed tendons within a tendon sheath. It provides direct visualization of the tendon end, allowing the clinician to assess the injury and facilitate retrieval. Used in clinical or surgical settings, the device assists in surgical decision-making by confirming the location of the retracted tendon, thereby potentially reducing the need for extensive surgical exploration and improving patient outcomes during tendon repair procedures.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Visualization device for tendon sheath access. No specific materials, energy sources, or software algorithms described.

## Regulatory Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

## Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 21 1997

Mr. James Hobbs
President
Luxtec Corporation
326 Clark Street
Worcester, Massachusetts 01606-1214

Re: K970642
Trade Name: TenoScope
Regulatory Class: II
Product Code: HRX
Dated: February 17, 1997
Received: February 20, 1997

Dear Mr. Hobbs:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - James Hobbs

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

![img-0.jpeg](img-0.jpeg)

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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# STATEMENT FOR INDICATIONS FOR USE

510(K) Number: K97056 /K970642

Device Name: TenoScope

Indications for Use:

The TenoScope is indicated for the visualization and diagnosis of a severed tendon which has retracted within its sheath and cannot be retrieved by non-invasive maneuvers.

![img-1.jpeg](img-1.jpeg)

![img-2.jpeg](img-2.jpeg)

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**Source:** [https://fda-staging.innolitics.com/device/K970642](https://fda-staging.innolitics.com/device/K970642)

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