Product code GCM
- Device name
- Endoscope, Rigid
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203226 | TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM | Richard Wolf Medical Instruments Corporation | 2021-05-14 |
| K083840 | MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE | Msi Medserv International Deutschland GmbH | 2009-09-28 |
| K001217 | INSIDE VIEW | Monadnock Optics, Inc. | 2000-07-11 |
| K993103 | ENDOSCOPES,10MM DIAMETER 0 DEGREES; ENDOSCOPES, 10MM DIAMETER, 30 DEGREES; ENDOSCOPES, 10MM DIAMETER, 50 DEGREES | Richard Wolf Medical Instruments Corp. | 1999-12-10 |
| K993445 | OMNISONIC ENDOSCOPIC DEFLECTOR | Omnisonics Medical Technologies | 1999-12-06 |
| K962393 | KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION | KARL STORZ Endoscopy-America, Inc. | 1996-09-17 |
| K950712 | PORTABLE ENDOSCOPY SYSTEM | Laser-Optik-Systeme GmbH & Co. KG | 1996-05-14 |
| K955120 | HAND-HELD RETRACTOR, DISSECTOR & DISSECTOR | Ethicon Endo-Surgery, Inc. | 1996-01-26 |
| K935235 | ENDOSCOPY SYSTEM FOR FACIAL PLASTIC SURGERY | Smith & Nephew Richards, Inc. | 1995-03-23 |
| K945889 | KARL STORZ PLASTIC SURGERY ACCESSORIES | KARL STORZ Endoscopy-America, Inc. | 1995-03-22 |
| K931954 | THORACOSCOPE/LAPAROSCOPE | Surgical Technologies, Inc. | 1993-11-02 |
| K921918 | FIBER OPTIC ENDOSCOPE | Electro Fiberoptics Corp. | 1993-08-17 |
| K925918 | PRESSURE TURING AND ACCESSORIES | Applied Medical Resources | 1993-02-12 |
| K921883 | ENDOSCOPE | Optimed Technologies, Inc. | 1992-11-23 |
| K901464 | MEDILASE SERIES 2200 ENDOSCOPE | Medical Laser, Inc. | 1990-08-07 |
| K894592 | LAMANO DIRECTORS | Marlo Surgical Technology | 1989-09-08 |
| K853514 | RIGID ENDOSCOPE | American Edwards Laboratories | 1985-10-04 |
| K844769 | RIGID FIBEROPITC ENDOSCOPE | Microvasive | 1985-01-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04055207007822 | NA | Richard Wolf GmbH | 2024-08-19 |
| 04055207008393 | NA | Richard Wolf GmbH | 2024-08-19 |
| 04055207058985 | NA | Richard Wolf GmbH | 2024-08-19 |
| 00198506002311 | ELMED | ELMED INCORPORATED | 2024-04-24 |
| 00198506002298 | ELMED | ELMED INCORPORATED | 2024-04-24 |
| 00198506002243 | ELMED | ELMED INCORPORATED | 2024-04-24 |
| 00198506002137 | ELMED | ELMED INCORPORATED | 2024-04-24 |
| 00198506001970 | ELMED | ELMED INCORPORATED | 2024-04-24 |
| 00842180187597 | ELMED | ELMED INCORPORATED | 2024-04-09 |
| 00842180185685 | ELMED | ELMED INCORPORATED | 2024-02-20 |
| 04053755125999 | DOUBLE INSUFFLATION BULB | Heine Optotechnik GmbH & Co. KG | 2022-12-12 |
| 04055207062920 | PANOVIEW ULTRA | Richard Wolf GmbH | 2021-05-25 |
| 04055207062913 | PANOVIEW ULTRA | Richard Wolf GmbH | 2021-05-25 |
| 04055207062890 | PANOVIEW ULTRA | Richard Wolf GmbH | 2021-05-25 |
| 04055207062944 | PANOVIEW ULTRA | Richard Wolf GmbH | 2021-05-25 |
| 04055207062937 | PANOVIEW ULTRA | Richard Wolf GmbH | 2021-05-25 |
| 04055207062906 | PANOVIEW ULTRA | Richard Wolf GmbH | 2021-05-25 |
| 04042761083492 | Olympus | OLYMPUS Winter & Ibe GmbH | 2020-07-31 |
| 04042761083485 | Olympus | OLYMPUS Winter & Ibe GmbH | 2020-07-31 |
| 04953170393112 | DVI CABLE 3M | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-05-27 |
| 04055207065761 | NA | Richard Wolf GmbH | 2020-05-06 |
| 04053755126859 | HEINE UniSpec® Disposable Tubes | Heine Optotechnik GmbH & Co. KG | 2016-09-24 |
| 04055207028612 | NA | Richard Wolf GmbH | 2016-09-23 |
| 04055207020944 | NA | Richard Wolf GmbH | 2016-09-23 |
| 04055207023778 | PANOVIEW PLUS | Richard Wolf GmbH | 2016-09-23 |
| 04055207022726 | PANOVIEW PLUS | Richard Wolf GmbH | 2016-09-23 |
| 04055207022719 | PANOVIEW PLUS | Richard Wolf GmbH | 2016-09-23 |
| 04055207028841 | PANOVIEW | Richard Wolf GmbH | 2016-09-23 |
| 04953170304866 | SDI Cable 8.5M | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |
| 04953170304927 | KEYBOARD | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |