Flexible Fiber Optic Endoscope
FDA 510(k) K922826 · Optimed Technologies, Inc.
510(k) numberK922826
Submission
- Device name
- Flexible Fiber Optic Endoscope
- Applicant
- Optimed Technologies, Inc.
Orange, CA, US - Received
- June 11, 1992
- Decision date
- February 19, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FGA – Kit, Nephroscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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| K232370 | Percutaneous Nephroscope SystemFGA · Traditional | Karl Storz SE & CO. KG | 05/01/2024SE |
| K151308 | Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetFGA · Traditional | Schoelly Fiberoptic GmbH | 02/09/2016SE |
| K072594 | Gyrus Acmi IPN-2505, Invisio Smith Percutaneous Nephroscope SystemFGA · Traditional | Gyrus Acmi, Inc. | 12/13/2007SE |
| K994223 | Nephroscope, 12 Degrees; Diaphragm Valve; Irrigation Attachment; Nephroscope, 20 Degree…FGA · Traditional | Richard Wolf Medical Instruments Corp. | 06/05/2000SE |
| K950433 | Karl Storz Endopyelotomy Set for Endoscopic Urology ProceduresFGA · Traditional | KARL STORZ Endoscopy-America, Inc. | 03/15/1995SE |
| K940594 | Karl Storz Adult & Pediatric NephroscopeFGA · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/09/1994SE |
| K853486 | Olympus Rigid Percutaneous NephroscopeFGA · Traditional | Olympus Corp. | 09/12/1985SE |
| K791182 | Acmi Rigi-Flex NephorscopeFGA · Traditional | American Cystocope Makers, Inc. | 07/30/1979SE |
| K770729 | Pyeloscope SystemFGA · Traditional | Richard Wolf Medical Instruments Corp. | 04/28/1977SE |
More from Richard Wolf Medical Instruments Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K972520 | OptiviewLLZ · Traditional | 09/29/1997SE |
| K955276 | Booster Lite 4 Motorized ScooterINI · Traditional | 11/04/1996SE |
| K955275 | Booster Trophy 5 Motorized ScooterINI · Traditional | 11/04/1996SE |
| K955274 | Booster Lite 3 Motorized ScooterINI · Traditional | 11/04/1996SE |
| K943598 | Flexible Fiber Optic LaparoscopesHET · Traditional | 10/18/1994SE |
| K926597 | Laparoscope, Gynecologic (and Accessories)HET · Traditional | 07/12/1994SE |
| K921942 | Hysteroscope (and Accessories)HIH · Traditional | 06/24/1994SE |
| K922711 | Flexible Fiber Optic Gynecologic EndoscopeHIH · Traditional | 05/17/1994SE |
| K921985 | Arthroscope & AccessoriesHRX · Traditional | 06/29/1993SE |
| K921883 | EndoscopeGCM · Traditional | 11/23/1992SE |
Questions and answers
When was Flexible Fiber Optic Endoscope cleared by the FDA?
Flexible Fiber Optic Endoscope (K922826) received a 510(k) decision of Substantially Equivalent on February 19, 1993, 253 days after the submission was received.
What is the product code of K922826?
The FDA product code is FGA – Kit, Nephroscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.