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Cabot Fiber Laser Probe

by Cabot Medical Corp. 510(k)

Active United States

510(k) K873115

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK873115 Date28 Jan 1988ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HET
Device Class
Class II
Regulation
21 CFR Part 884.1720
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Cabot Fiber Laser Probe is a laparoscope, gynecologic (and accessories) device used in obstetrics and gynecology. It is a fiber laser probe designed for use in laparoscopic procedures within the gynecologic specialty.

The device received traditional 510(k) clearance (K873115) from the FDA on January 28, 1988, and is classified as a Class II medical device. It is supplied as a reusable or single-use accessory for laparoscopic systems, with no stated sterility, MRI safety, or storage requirements in the provided data.

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Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Cabot Fiber Laser Probe used for?

    The Cabot Fiber Laser Probe is a laparoscope, gynecologic (and accessories) device designed for use in laparoscopic procedures within the obstetrics and gynecology specialty, as indicated in its FDA 510(k) clearance documentation.

  • Is the Cabot Fiber Laser Probe reusable or single-use?

    The device is supplied as either a reusable or single-use accessory for laparoscopic systems, according to the provided device data, which does not specify a fixed use type but allows both configurations.

  • What regulatory pathway was used for the Cabot Fiber Laser Probe?

    The Cabot Fiber Laser Probe received traditional 510(k) clearance from the FDA under K number K873115 on January 28, 1988, and is classified as a Class II medical device under regulation number 884.1720.