Laparoscopic Basket Flexible and Rigid
by United States Endoscopy Group, Inc. 510(k)
Active
510(k) K911477
Overview
A laparoscopic basket flexible and rigid is a device used for retrieving stones or fragments during minimally invasive procedures. It is classified as a biliary mechanical lithotriptor under FDA product code LQC and regulation number 876.4500.
This device received traditional 510(k) clearance (K911477) from the United States Endoscopy Group, Inc. on August 14, 1991, following submission on April 4, 1991. It is indicated for use in gastroenterology and urology specialties, as determined by the GU advisory committee.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK911477 | Date14 Aug 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LQC
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.4500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from United States Endoscopy Group, Inc.
Questions
What is the laparoscopic basket flexible and rigid used for?
This device is used for retrieving stones or fragments during minimally invasive procedures, specifically indicated for biliary mechanical lithotripsy in gastroenterology and urology specialties as determined by the GU advisory committee.
How was the laparoscopic basket flexible and rigid cleared for market?
The device received traditional 510(k) clearance (K911477) from the FDA on August 14, 1991, following submission on April 4, 1991, based on a determination of substantial equivalence to a predicate device.
What regulatory classification and product code apply to this device?
It is classified as a biliary mechanical lithotriptor under FDA product code LQC and regulation number 876.4500, with a device class of II, as indicated in the openFDA data.