Cabot Fiber Laser Probe
by Cabot Medical Corp. 510(k)
Active
510(k) K873115
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK873115 | Date28 Jan 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 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
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.
Other devices from Cabot Medical Corp.
Questions
AI-generated answers, 27 Sep 2026
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.