Tenoscope

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K970642 ↗

FDA Product Code

HRX

Device Class

Class II

Regulation

21 CFR Part 888.1100

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Frazier Suction Tube

  Class I

  FDA 510(k) K864382 Active Cleared 14 Jan 1987

• Lutex Headlight Systems

  Class II

  FDA 510(k) K864380 Active Cleared 19 Nov 1986

• Luxtec Fiberoptic Cables

  Class I

  FDA 510(k) K864387 Active Cleared 22 May 1987

• Luxtec Aco Series 4000 Light Source

  Class II

  FDA 510(k) K890716 Active Cleared 26 Apr 1989

• Luxtec Retractors, Luxtec Specialty Retractors

  Class I

  FDA 510(k) K864384 Active Cleared 19 Nov 1986

• Luxscope

  Class II

  FDA 510(k) K973193 Active Cleared 21 Nov 1997

See all devices from Luxtec Corp. →

• What clinical situations is the Tenoscope designed to address specifically?

  The Tenoscope is intended for visualizing and assessing tendon integrity in cases where tendons have been severed and retracted within their sheath, making them difficult to locate using non-invasive retrieval methods. It is particularly useful in orthopedic settings where traditional techniques have failed to identify the tendon’s location.

• Is the Tenoscope meant for single-use or can it be reused in multiple procedures?

  The Tenoscope is explicitly supplied as a reusable medical instrument, meaning it is designed for repeated use in clinical settings after proper cleaning and maintenance. There are no notes in the available data indicating it requires single-use or has sterility requirements beyond standard reusable orthopedic instrument protocols.

• How was the Tenoscope’s regulatory pathway determined, and what does that mean for its use?

  The Tenoscope was classified as substantially equivalent to a predicate device under the FDA’s 510(k) process, specifically under the HRX product code (Orthopedic Instruments). This means its safety and effectiveness were compared to an existing device already on the market, and it received clearance in 1997. Clinically, this pathway confirms it meets FDA standards for orthopedic visualization tools without requiring additional approvals beyond its original clearance.

• Who should I contact if I need more details about the Tenoscope’s specifications or support?

  For inquiries regarding the Tenoscope, you can reach Luxtec Corp. through their listed contact, Joseph Ress, at their Newton, MA office (45 Pontiac Rd., 02168). This is the official applicant and manufacturer for the device, as noted in the FDA submission records.