Tubal Occlusion Inserter/Laparoscope
by Kli
510(k) K771960
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK771960 | Date25 Oct 1977 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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, 25 Sep 2026
This device is a tubal occlusion inserter/laparoscope, classified as a laparoscope, gynecologic (and accessories) under product code HET. It is a Class II medical device subject to special controls.
It received FDA 510(k) clearance (K771960) on October 25, 1977, following a traditional submission. The device is manufactured by Kli in McHenry, Illinois, United States.
Other devices from Kli
Questions
AI-generated answers, 25 Sep 2026
What is the tubal occlusion inserter/laparoscope used for?
This device is a tubal occlusion inserter/laparoscope, classified as a laparoscope, gynecologic (and accessories) under product code HET, and is used in gynecologic procedures for tubal occlusion and laparoscopic visualization.
Who manufactures the tubal occlusion inserter/laparoscope and where is it made?
The device is manufactured by Kli in McHenry, Illinois, United States, as specified in the device data.
What regulatory pathway was used for the tubal occlusion inserter/laparoscope?
The device received FDA 510(k) clearance via a traditional submission, with clearance granted on October 25, 1977, under K771960, and is classified as a Class II medical device subject to special controls.
What is the product code and device classification for the tubal occlusion inserter/laparoscope?
The device is classified under product code HET as a laparoscope, gynecologic (and accessories), and is a Class II medical device, as indicated in the openfda and product_code fields.