Endoscope, Ac-Powered And Accessories
FDA product code GCP · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
13510(k) clearances
0PMA approvals
5recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954614 | Eos Brand Disposable ProctoscopeGCP · Traditional | North Eos Industries, Inc. | 04/10/1996SE |
| K896505 | Porges Universal HandlesGCP · Traditional | Porges Corp. | 01/30/1990SE |
| K896008 | Model 6500 Mercury Arc Light SourceGCP · Traditional | Medical Dynamics, Inc. | 12/27/1989SE |
| K862424 | Steerable Catheter SystemGCP · Traditional | Endovations | 09/22/1986SE |
| K860103 | Mod. Endoport Single-Use Trocar and SleeveGCP · Traditional | Endotherapeutics | 02/12/1986SE |
| K843683 | Modular Fiberscope SystemGCP · Traditional | Reichert Scientific Instruments | 01/18/1985SE |
| K833859 | Tamponade Balloon CuffGCP · Traditional | American Endoscopy, Inc. | 01/03/1984SE |
| K821999 | Endoscopic Sclerotherapy BalloonGCP · Traditional | Retech | 08/27/1982SE |
| K801247 | CCD Endoscope and AttachmentsGCP · Traditional | Welch Allyn, Inc. | 07/28/1980SE |
| K790071 | Endoscope and AccessoriesGCP · Traditional | Olympus Corp. | 04/02/1979SE |
| K771920 | Fiber Optics ProctoscopeGCP · Traditional | Propper Mfg. Co., Inc. | 10/20/1977SE |
| K771919 | Fiber Optics SigmoidoscopeGCP · Traditional | Propper Mfg. Co., Inc. | 10/20/1977SE |
| K771918 | Fibeo Optics Illum. SystemGCP · Traditional | Propper Mfg. Co., Inc. | 10/20/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1454-2026 Class II | Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in…Complaints of the ceramic tip of the resection sheath breaking have been received. | Olympus Corporation of the Americas | 11/11/2025Open, Classified |
| Z-1437-2026 Class II | Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH… | Olympus Corporation of the Americas | 09/13/2024Open, Classified |
| Z-0351-2025 Class II | Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number: WA22810A…Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the… | Olympus Corporation of the Americas | 09/13/2024Open, Classified |
| Z-0696-2018 Class II | A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one…Olympus has received complaints about fragments of adhesive which detached from inside the working channel… | Olympus Corporation of the Americas | 08/18/2017Terminated |
| Z-2629-2017 Class II | High Frequency Resection Electrodes, endoscope, ac-powered and accessories The…Loop wires breaking at the distal end of the Monopolar HF Resection Electrodes. | Olympus Corporation of the Americas | 04/19/2017Terminated |