FDA product code GBS: Catheter, Ventricular, General & Plastic Surgery
GBS is the FDA product code for catheter, ventricular, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel. FDA has cleared 27 510(k) submissions under GBS, from 18 different applicants. The average 510(k) review took 39 days (median 28). FDA has posted 20 recalls for GBS devices.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Ventricular, General & Plastic Surgery |
| Device class | Class I |
| Regulation | 21 CFR 878.4200 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GBS clearance
Top GBS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| H.W. Andersen Products, Inc. | 3 | 1987-07-23 |
| Axiom Medical, Inc. | 3 | 1986-08-29 |
| Sheridan Catheter Corp. | 2 | 1988-05-18 |
| Uresil Corp. | 2 | 1988-03-14 |
| Sil-Med Corp. | 2 | 1986-08-07 |
13 more applicants have GBS clearances. See the full list in Caduvo.
Most recent GBS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K912645 | Atrium Medical Corp. | ATRIUMS PDR THORACIC CATHETER | 1991-09-13 | 88 |
| K883887 | Axiom, Inc. | AXIOM ATRAUM WOUND DRAINS | 1989-02-17 | 157 |
| K881873 | Sheridan Catheter Corp. | INTRODUCTION/DRAINAGE CATHETER & ACCESS | 1988-05-18 | 15 |
| K880895 | Uresil Corp. | URESIL WOUND DRAIN TROCAR | 1988-03-14 | 12 |
| K880376 | Genesis Industries, Inc. | NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP | 1988-02-16 | 20 |
Recalls for GBS devices
20 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-08-10.
Frequently asked questions
What is FDA product code GBS?
GBS is the FDA product code for catheter, ventricular, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel.
What device class is GBS?
Class I, regulation 21 CFR 878.4200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GBS?
Across 27 cleared submissions the average was 39 days from receipt to decision (median 28).
Which companies have the most GBS clearances?
H.W. Andersen Products, Inc. (3); Axiom Medical, Inc. (3); Sheridan Catheter Corp. (2); Uresil Corp. (2); Sil-Med Corp. (2).
Have GBS devices been recalled?
Yes: 20 product recalls across 3 recall events; the most recent began 2010-08-10.
Next steps
- Run an FDA pathway report with predicate devices for product code GBS
- Run a recall and safety report across every GBS manufacturer
- Watch product code GBS 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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