FDA product code FDG: Retractor, Fiberoptic
FDG is the FDA product code for retractor, fiberoptic. It is a Class I device, regulated under 21 CFR 876.4530 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 2 510(k) submissions under FDG, from 2 different applicants. The average 510(k) review took 70 days (median 70). FDA has posted 2 recalls for FDG devices.
Classification
| Field | Value |
|---|---|
| Device name | Retractor, Fiberoptic |
| Device class | Class I |
| Regulation | 21 CFR 876.4530 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FDG clearance
Top FDG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bioenterics Corp. | 1 | 1997-02-11 |
| Stephen Chakoff, Inc. | 1 | 1994-12-23 |
Most recent FDG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K964561 | Bioenterics Corp. | ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TA | 1997-02-11 | 90 |
| K945421 | Stephen Chakoff, Inc. | CHAKOFF ENDOSCOPY | 1994-12-23 | 49 |
Recalls for FDG devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-07-01.
Frequently asked questions
What is FDA product code FDG?
FDG is the FDA product code for retractor, fiberoptic. It is a Class I device, regulated under 21 CFR 876.4530 and reviewed by the Gastroenterology and Urology panel.
What device class is FDG?
Class I, regulation 21 CFR 876.4530. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FDG?
Across 2 cleared submissions the average was 70 days from receipt to decision (median 70).
Which companies have the most FDG clearances?
Bioenterics Corp. (1); Stephen Chakoff, Inc. (1).
Have FDG devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2009-07-01.
Next steps
- Run an FDA pathway report with predicate devices for product code FDG
- Run a recall and safety report across every FDG manufacturer
- Watch product code FDG 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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