Endoscope, Rigid
FDA product code GCM · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
18510(k) clearances
0PMA approvals
0recalls
Manufacturers
- KARL STORZ Endoscopy-America, Inc. 2
- Richard Wolf Medical Instruments Corp. 2
- Microvasive 1
- American Edwards Laboratories 1
- Marlo Surgical Technology 1
- Medical Laser, Inc. 1
- Optimed Technologies, Inc. 1
- Applied Medical Resources Corp 1
- Electro Fiberoptics Corp. 1
- Surgical Technologies, Inc. 1
- Smith & Nephew Richards, Inc. 1
- Ethicon Endo-Surgery, Inc. 1
- Laser-Optik-Systeme GmbH & Co. KG 1
- Omnisonics Medical Technologies 1
- Monadnock Optics, Inc. 1
- Msi Medserv International Deutschland GmbH 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203226 | Telescope 0 O 10MM WL 305MM / Telescope 30 O 10MM WL 305MM / Telescope 50 O 10MM WL…GCM · Traditional | Richard Wolf Medical Instruments Corporation | 05/14/2021SE |
| K083840 | Msi Medserv International-Rigid EndoscopeGCM · Traditional | Msi Medserv International Deutschland GmbH | 09/28/2009SE |
| K001217 | Inside ViewGCM · Traditional | Monadnock Optics, Inc. | 07/11/2000SE |
| K993103 | ENDOSCOPES,10MM Diameter 0 Degrees; Endoscopes, 10MM Diameter, 30 Degrees; Endoscopes…GCM · Traditional | Richard Wolf Medical Instruments Corp. | 12/10/1999SE |
| K993445 | Omnisonic Endoscopic DeflectorGCM · Traditional | Omnisonics Medical Technologies | 12/06/1999SE |
| K962393 | Ksea Set for Endoscopic Assisted IntubationGCM · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/17/1996SE |
| K950712 | Portable Endoscopy SystemGCM · Traditional | Laser-Optik-Systeme GmbH & Co. KG | 05/14/1996SE |
| K955120 | Hand-Held Retractor, Dissector & DissectorGCM · Traditional | Ethicon Endo-Surgery, Inc. | 01/26/1996SE |
| K935235 | Endoscopy System for Facial Plastic SurgeryGCM · Traditional | Smith & Nephew Richards, Inc. | 03/23/1995SE |
| K945889 | Karl Storz Plastic Surgery AccessoriesGCM · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/22/1995SE |
| K931954 | Thoracoscope/LaparoscopeGCM · Traditional | Surgical Technologies, Inc. | 11/02/1993SE |
| K921918 | Fiber Optic EndoscopeGCM · Traditional | Electro Fiberoptics Corp. | 08/17/1993SE |
| K925918 | Pressure Turing and AccessoriesGCM · Traditional | Applied Medical Resources | 02/12/1993SE |
| K921883 | EndoscopeGCM · Traditional | Optimed Technologies, Inc. | 11/23/1992SE |
| K901464 | Medilase Series 2200 EndoscopeGCM · Traditional | Medical Laser, Inc. | 08/07/1990SE |
| K894592 | Lamano DirectorsGCM · Traditional | Marlo Surgical Technology | 09/08/1989SE |
| K853514 | Rigid EndoscopeGCM · Traditional | American Edwards Laboratories | 10/04/1985SE |
| K844769 | Rigid Fiberopitc EndoscopeGCM · Traditional | Microvasive | 01/15/1985SE |