FDA product code GDB: Endoscope, Fiber Optic
GDB is the FDA product code for endoscope, fiber optic. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 7 510(k) submissions under GDB, from 7 different applicants. The average 510(k) review took 102 days (median 64).
Classification
| Field | Value |
|---|---|
| Device name | Endoscope, Fiber Optic |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every GDB clearance
Top GDB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Designs For Vision, Inc. | 1 | 2003-08-20 |
| Matrix Medica, Inc. | 1 | 1996-09-18 |
| Cuda Products Co. | 1 | 1994-07-13 |
| Olympus Corp. | 1 | 1988-11-15 |
| Regtec | 1 | 1986-02-19 |
2 more applicants have GDB clearances. See the full list in Caduvo.
Most recent GDB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K032283 | Designs For Vision, Inc. | DESIGNS FOR VISION FIBEROPTIC LIGHT | 2003-08-20 | 27 |
| K961536 | Matrix Medica, Inc. | FLEXSCOPE | 1996-09-18 | 149 |
| K935818 | Cuda Products Co. | ENDOSCOPE | 1994-07-13 | 223 |
| K882061 | Olympus Corp. | OLYMPUS GF-UM3/EU-M3 | 1988-11-15 | 183 |
| K855151 | Regtec | FRITCH OPHTHALMIC ENDOSCOPE | 1986-02-19 | 55 |
Recalls for GDB devices
openFDA lists no recalls for product code GDB.
Frequently asked questions
What is FDA product code GDB?
GDB is the FDA product code for endoscope, fiber optic. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is GDB?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code GDB?
Across 7 cleared submissions the average was 102 days from receipt to decision (median 64).
Which companies have the most GDB clearances?
Designs For Vision, Inc. (1); Matrix Medica, Inc. (1); Cuda Products Co. (1); Olympus Corp. (1); Regtec (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GDB
- Run a recall and safety report across every GDB manufacturer
- Watch product code GDB 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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