FDA product code FBQ: Trocar, Gastro-Urology
FBQ is the FDA product code for trocar, gastro-urology. It is a Class II device, regulated under 21 CFR 876.5090 and reviewed by the General and Plastic Surgery panel. FDA has cleared 9 510(k) submissions under FBQ, from 7 different applicants. The average 510(k) review took 59 days (median 64). FDA has posted 25 recalls for FBQ devices, 25 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Trocar, Gastro-Urology |
| Device class | Class II |
| Regulation | 21 CFR 876.5090 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FBQ clearance
Top FBQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Gabris Surgical Corp. | 2 | 1994-10-11 |
| United States Surgical, A Division of Tyco Healthc | 2 | 1994-08-22 |
| Gibbons Surgical Corp. | 1 | 2001-08-09 |
| Endoscopic Concepts, Inc. | 1 | 1998-04-01 |
| Aesculap, Inc. | 1 | 1993-12-23 |
2 more applicants have FBQ clearances. See the full list in Caduvo.
Most recent FBQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K012198 | Gibbons Surgical Corp. | GIBBONS STERILE TROCAR KITS | 2001-08-09 | 27 |
| K980804 | Endoscopic Concepts, Inc. | SABRE BT BLUNT0TIP SURGICAL TROCAR | 1998-04-01 | 30 |
| K944640 | Gabris Surgical Corp. | LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT | 1994-10-11 | 20 |
| K944104 | Gabris Surgical Corp. | GABRIS LAPAROSCOPIC SURGICAL KITS | 1994-09-13 | 21 |
| K942885 | United States Surgical, A Division of Tyco Healthc | AUTO SUTURE MODIFIED GRIP | 1994-08-22 | 66 |
Recalls for FBQ devices
25 product recalls in 1 recall events; 25 initiated in the last five years and 0 still open. Most recent: 2022-02-22.
| Year | Recalls |
|---|---|
| 2022 | 25 |
Frequently asked questions
What is FDA product code FBQ?
FBQ is the FDA product code for trocar, gastro-urology. It is a Class II device, regulated under 21 CFR 876.5090 and reviewed by the General and Plastic Surgery panel.
What device class is FBQ?
Class II, regulation 21 CFR 876.5090. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FBQ?
Across 9 cleared submissions the average was 59 days from receipt to decision (median 64).
Which companies have the most FBQ clearances?
Gabris Surgical Corp. (2); United States Surgical, A Division of Tyco Healthc (2); Gibbons Surgical Corp. (1); Endoscopic Concepts, Inc. (1); Aesculap, Inc. (1).
Have FBQ devices been recalled?
Yes: 25 product recalls across 1 recall events; the most recent began 2022-02-22.
Next steps
- Run an FDA pathway report with predicate devices for product code FBQ
- Run a recall and safety report across every FBQ manufacturer
- Watch product code FBQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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