FDA product code GBL: Catheter, Ureteral, General & Plastic Surgery
GBL is the FDA product code for catheter, ureteral, general & plastic surgery. It is a Not classified device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel. Devices under GBL reach the market by Contact FDA; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for GBL devices.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Ureteral, General & Plastic Surgery |
| Device class | Not classified |
| Regulation | 21 CFR 876.5130 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | Contact FDA |
| Third-party 510(k) review eligible | Yes |
Recalls for GBL devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-01-04.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code GBL?
GBL is the FDA product code for catheter, ureteral, general & plastic surgery. It is a Not classified device, regulated under 21 CFR 876.5130 and reviewed by the Gastroenterology and Urology panel.
What device class is GBL?
Not classified, regulation 21 CFR 876.5130. Typical premarket route: Contact FDA.
Have GBL devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2019-01-04.
Next steps
- Run an FDA pathway report with predicate devices for product code GBL
- Run a recall and safety report across every GBL manufacturer
- Watch product code GBL 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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