FDA product code GBN: Catheter, Pediatric, General & Plastic Surgery
GBN is the FDA product code for catheter, pediatric, 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 2 510(k) submissions under GBN, from 2 different applicants. The average 510(k) review took 84 days (median 84). FDA has posted 1 recall for GBN devices.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Pediatric, 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 GBN clearance
Top GBN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Armm, Inc. | 1 | 1993-08-06 |
| Hospital Products Intl. | 1 | 1980-12-16 |
Most recent GBN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K931607 | Armm, Inc. | MEDDRAINS | 1993-08-06 | 127 |
| K802783 | Hospital Products Intl. | SURGEONS CHOICE STAPLE, REMOVE/IMPLANT | 1980-12-16 | 42 |
Recalls for GBN devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-10-08.
Frequently asked questions
What is FDA product code GBN?
GBN is the FDA product code for catheter, pediatric, 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 GBN?
Class I, regulation 21 CFR 878.4200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GBN?
Across 2 cleared submissions the average was 84 days from receipt to decision (median 84).
Which companies have the most GBN clearances?
Armm, Inc. (1); Hospital Products Intl. (1).
Have GBN devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2014-10-08.
Next steps
- Run an FDA pathway report with predicate devices for product code GBN
- Run a recall and safety report across every GBN manufacturer
- Watch product code GBN 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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