Trocar, Gastro-Urology
The Gastro-Urology Trocar (product code FBQ) is a pointed surgical instrument used to puncture the abdominal wall or body cavity to gain access for a cannula during laparoscopic or urological procedures. It is an FDA Class 2 device (moderate risk), subject to general controls with no 510(k) required under the applicable submission type. It is regulated under 21 CFR 876.5090 in the Gastroenterology and Urology specialty. No special flags apply.
Research product code FBQ in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- FBQ
- Device Class
- FDA class 2
- Regulation Number
- 876.5090
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K012198 | GIBBONS STERILE TROCAR KITS | Aug 09, 2001 | Substantially Equivalent | Gibbons Surgical Corp. |
| K980804 | SABRE BT BLUNT0TIP SURGICAL TROCAR | Apr 01, 1998 | Substantially Equivalent | Endoscopic Concepts, Inc. |
| K944640 | LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT | Oct 11, 1994 | Substantially Equivalent | Gabris Surgical Corp. |
| K944104 | GABRIS LAPAROSCOPIC SURGICAL KITS | Sep 13, 1994 | Substantially Equivalent | Gabris Surgical Corp. |
| K942885 | AUTO SUTURE MODIFIED GRIP | Aug 22, 1994 | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc |
| K934724 | AESCULAP TROCAR INSTRUMENT SET | Dec 23, 1993 | Substantially Equivalent | Aesculap, Inc. |
| K904638 | TROCAR DISPOSABLE | Feb 21, 1991 | Substantially Equivalent | L.A.S.E.R., Inc. |
| K900123 | AUTO SUTURE SURGIPORT SPIRAL SLEEVE | Apr 04, 1990 | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc |
| K841716 | ENDOPORT EROCAR | Jun 28, 1984 | Substantially Equivalent | Endotherapeutics |
FEI Numbers
This FDA classification entry is associated with 38 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 38 registration numbers. Click on an entry to view related FDA registrations.