Carrier, Sponge, Endoscopic
FDA product code FGS · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
4510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933604 | QB II Blunt DissectorFGS · Traditional | Joyce M. Shotwell, M.D. | 09/23/1993SE |
| K931854 | Endoscopic Blunt Dissecting InstrumentFGS · Traditional | Mayaguez Medical Center | 08/10/1993SE |
| K923818 | O.R. Concepts' Irrigating KittnerFGS · Traditional | O.R. Concepts, Inc. | 04/07/1993SE |
| K822194 | Endoscopic Sponge CarrierFGS · Traditional | Kelleher Corp. | 08/27/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0906-2011 | InfraVision IR Illuminator Console, model number 220-180-521, manufactured by Stryker…Product may not adequately visualize IR light emitted from U- and E- kits due to a manufacturing error. | Stryker Endoscopy | 09/29/2010Terminated |