Surgical Trocar and Trocar Sleeve
510(k) K932229
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK932229 | Date18 Aug 1993 | 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- Withdrawn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
- GCJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.1500
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Surgical Trocar and Trocar Sleeve is a laparoscopic device used in general and plastic surgery procedures. It facilitates access to the abdominal cavity by creating a controlled entry point for instruments, allowing for minimally invasive surgical interventions in specialties such as gastroenterology and urology. The trocar consists of a sharp, pointed tip designed to pierce tissue, while the sleeve provides a protective sheath to maintain a seal and prevent gas leakage during the procedure.
This device is supplied sterile for single-use and is classified under FDA product code GCJ. It is intended for use in operating room settings and must comply with regulatory standards for surgical instruments. The trocar and sleeve are designed to be compatible with laparoscopic equipment and are cleared under the FDA’s 510(k) pathway as substantially equivalent to predicate devices. Storage and handling follow standard sterile surgical instrument protocols to ensure safety and efficacy.