Acmi Rigi-Flex Nephorscope
FDA 510(k) K791182 · American Cystocope Makers, Inc.
510(k) numberK791182
Submission
- Device name
- Acmi Rigi-Flex Nephorscope
- Applicant
- American Cystocope Makers, Inc.
Mchenry, IL, US - Received
- June 25, 1979
- Decision date
- July 30, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FGA – Kit, Nephroscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FGA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K922826 | Flexible Fiber Optic EndoscopeFGA · Traditional | Optimed Technologies, Inc. | 02/19/1993SE |
| K853486 | Olympus Rigid Percutaneous NephroscopeFGA · Traditional | Olympus Corp. | 09/12/1985SE |
| K770729 | Pyeloscope SystemFGA · Traditional | Richard Wolf Medical Instruments Corp. | 04/28/1977SE |
More from Richard Wolf Medical Instruments Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K832040 | Sterile Fluid Producing Unit #EP550LJH · Traditional | 09/29/1983SE |
| K812637 | Acmi Bipolar Hemostatic SourceGEI · Traditional | 10/26/1981SE |
| K811218 | Acmi Aspirator Kit #8808EOQ · Traditional | 07/01/1981SE |
| K803214 | Acmi Bipolar Hemostatic ElectrodeFEH · Traditional | 01/15/1981SE |
| K770754 | Duodenoscope, Molel TX-6FOG · Traditional | 04/28/1977SE |
| K760822 | Model TX-8 PanendoscopeFAK · Traditional | 10/21/1976SE |
| K760452 | Colonoscope, 2-CHANNEL Log (Acmi TX-92)FDF · Traditional | 08/30/1976SE |
| K760451 | Air Water Source (Acmi Model 710)OCX · Traditional | 08/30/1976SE |
Questions and answers
When was Acmi Rigi-Flex Nephorscope cleared by the FDA?
Acmi Rigi-Flex Nephorscope (K791182) received a 510(k) decision of Substantially Equivalent on July 30, 1979, 35 days after the submission was received.
What is the product code of K791182?
The FDA product code is FGA – Kit, Nephroscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.