510(k) K922826
- Device
- FLEXIBLE FIBER OPTIC ENDOSCOPE
- Applicant
- OPTIMED TECHNOLOGIES, INC.
- 510(k) number
- K922826
- Product code
- FGA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-02-19
- Date received
- 1992-06-11
- Regulation
- 876.1500
- Classification name
- Kit, Nephroscope
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RONALD J EHMSEN
- Address
- 2440 N. Glassell St. Suite J Orange CA US 92665 92665
FDA Registration Numbers#
- 3006546082
- 8010487
- 3011986317
- 3013247477
- 1825146
- 3023460764
- 9610617
- 3010202439
- 9611102
- 2020550
- 9610773
- 8010349
- 1000343527
- 3017425975
- 3008386005
- 3014893827
- 3014644276
- 3011050570
- 3014342096
- 3010419931
- 1221826
- 3013031133
- 3023102955
- 3025482817
- 3014279513
- 3010400865
- 8043903
- 1820334
- 2030624
- 1418479
- 3004361445
- 3010707607
- 9614434
- 3013497507
Source Documents#
Other 510(k) Records For Product Code FGA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232370 | Percutaneous Nephroscope System | Karl Storz SE & CO. KG | 2024-05-01 |
| K151308 | Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set | Schoelly Fiberoptic GmbH | 2016-02-09 |
| K072594 | GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM | Gyrus Acmi, Inc. | 2007-12-13 |
| K994223 | NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20 | Richard Wolf Medical Instruments Corp. | 2000-06-05 |
| K950433 | KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES | KARL STORZ Endoscopy-America, Inc. | 1995-03-15 |
| K940594 | KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE | KARL STORZ Endoscopy-America, Inc. | 1994-09-09 |
| K853486 | OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE | Olympus Corp. | 1985-09-12 |
| K791182 | ACMI RIGI-FLEX NEPHORSCOPE | American Cystocope Makers, Inc. | 1979-07-30 |
| K770729 | PYELOSCOPE SYSTEM | Richard Wolf Medical Instruments Corp. | 1977-04-28 |
Legacy Summary#
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FDA Review#
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