Laryngoscope, Endoscope
FDA product code GCI · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
14510(k) clearances
0PMA approvals
5recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K021747 | Degall Laparoscopic Gallbladder ExtractorGCI · Traditional | Surgicon, Inc. | 08/15/2002SE |
| K003222 | Modification to Hermes Operating Room Control CenterGCI · Special | Computer Motion, Inc. | 11/03/2000SE |
| K001362 | Karl Storz 3D Video SystemGCI · Traditional | Karl Storz Imaging, Inc. | 07/17/2000SE |
| K933515 | Booty Endoscope WarmerGCI · Traditional | T-Med, Inc. | 10/27/1993SE |
| K930302 | Birtcher Sure Clean Instrument SystemGCI · Traditional | Birtcher Medical Systems, Inc. | 10/27/1993SE |
| K930496 | GI-1090,1095,1080,1085,1086,1088, Endo. ClampsGCI · Traditional | Birtcher Medical Systems, Inc. | 04/20/1993SE |
| K922123 | Auto Suture Disposable Endoscopic Specimen PouchGCI · Traditional | United States Surgical, A Division of Tyco Healthc | 02/01/1993SE |
| K920139 | Gleeson Clot-BusterGCI · Traditional | Conmedcorp | 04/15/1992SE |
| K915762 | Poole Tip Suction ProbeGCI · Traditional | O.R. Concepts, Inc. | 03/13/1992SE |
| K914120 | Single Use Laparoscopy Electrosurgical InstrumentGCI · Traditional | Conmedcorp | 10/30/1991SE |
| K911829 | EndostapleGCI · Traditional | ETHICON, Inc. | 08/28/1991SE |
| K911461 | SurgitronGCI · Traditional | Ellman Intl. Mfg., Inc. | 04/25/1991SE |
| K905117 | Endoscope and AccessoriesGCI · Traditional | Northgate Technologies, Inc. | 04/25/1991SE |
| K896205 | Monoscopy Brand, 5 MM Locking Trocar SleeveGCI · Traditional | Dexide, Inc. | 03/22/1990SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2255-2020 Class II | Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No.…The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly… | Covidien Llc | 05/12/2020Open, Classified |
| Z-2254-2020 Class II | Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No.…The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly… | Covidien Llc | 05/12/2020Open, Classified |
| Z-2253-2020 Class II | Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage:…The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly… | Covidien Llc | 05/12/2020Open, Classified |
| Z-2252-2020 Class II | Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage:…The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly… | Covidien Llc | 05/12/2020Open, Classified |
| Z-2216-2015 Class II | Medical Device Exchange - Endo Catch 10mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only…EXP did not register as a medical device establishment, list the devices being recalled, or establish its… | EXP Pharmaceutical Services Corp | 02/11/2015Terminated |