FDA product code FGS: Carrier, Sponge, Endoscopic
FGS is the FDA product code for carrier, sponge, endoscopic. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 4 510(k) submissions under FGS, from 4 different applicants. The average 510(k) review took 116 days (median 88). FDA has posted 1 recall for FGS devices.
Classification
| Field | Value |
|---|---|
| Device name | Carrier, Sponge, Endoscopic |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FGS clearance
Top FGS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Joyce M. Shotwell, M.D. | 1 | 1993-09-23 |
| Mayaguez Medical Center | 1 | 1993-08-10 |
| O.R. Concepts, Inc. | 1 | 1993-04-07 |
| Kelleher Corp. | 1 | 1982-08-27 |
Most recent FGS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K933604 | Joyce M. Shotwell, M.D. | QB II BLUNT DISSECTOR | 1993-09-23 | 58 |
| K931854 | Mayaguez Medical Center | ENDOSCOPIC BLUNT DISSECTING INSTRUMENT | 1993-08-10 | 119 |
| K923818 | O.R. Concepts, Inc. | O.R. CONCEPTS' IRRIGATING KITTNER | 1993-04-07 | 251 |
| K822194 | Kelleher Corp. | ENDOSCOPIC SPONGE CARRIER | 1982-08-27 | 35 |
Recalls for FGS devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-09-29.
Frequently asked questions
What is FDA product code FGS?
FGS is the FDA product code for carrier, sponge, endoscopic. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FGS?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FGS?
Across 4 cleared submissions the average was 116 days from receipt to decision (median 88).
Which companies have the most FGS clearances?
Joyce M. Shotwell, M.D. (1); Mayaguez Medical Center (1); O.R. Concepts, Inc. (1); Kelleher Corp. (1).
Have FGS devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-09-29.
Next steps
- Run an FDA pathway report with predicate devices for product code FGS
- Run a recall and safety report across every FGS manufacturer
- Watch product code FGS 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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