Panels › Gastroenterology, Urology › Product code FGS · Class 2
Carrier, Sponge, Endoscopic
Regulation 876.1500
0510(k)s in 12 months (4 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in FGS
| Company | 510(k)s | Recalls |
|---|---|---|
| Joyce M. Shotwell, M.D. | 1 | 0 |
| Kelleher Corp. | 1 | 0 |
| Mayaguez Medical Center | 1 | 0 |
| O.R. Concepts, Inc. | 1 | 0 |
| Stryker Endoscopy | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 23, 1993 | K933604 | QB II BLUNT DISSECTOR Joyce M. Shotwell, M.D. | FGS |
| Aug 10, 1993 | K931854 | ENDOSCOPIC BLUNT DISSECTING INSTRUMENT Mayaguez Medical Center | FGS |
| Apr 7, 1993 | K923818 | O.R. CONCEPTS' IRRIGATING KITTNER O.R. Concepts, Inc. | FGS |
| Aug 27, 1982 | K822194 | ENDOSCOPIC SPONGE CARRIER Kelleher Corp. | FGS |
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