510(k) K970598
- Device
- INTEGRATED VISUALIZATION SYSTEM
- Applicant
- UROHEALTH, INC.
- 510(k) number
- K970598
- Product code
- FCW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-03-12
- Date received
- 1997-02-18
- Regulation
- 876.1500
- Classification name
- Light Source, Fiberoptic, Routine
- 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 BERGESON
- Address
- 3050 Redhill Ave. Costa Mesa CA US 92626 92626
FDA Registration Numbers#
- 3004001706
- 3008569850
- 2518897
- 3015612252
- 3004464325
- 9615782
- 3006984716
- 9611102
- 3006546082
- 3013247477
- 3010120217
- 3003418325
- 3012322232
- 1035968
- 3014334038
- 3011676349
- 3004215117
- 1320894
- 9611274
- 9612074
- 1222275
- 3007303113
- 3006765019
- 3011277660
- 1221826
- 3009656988
- 3002807314
- 9610877
- 3013002167
- 3007137643
- 3007305485
- 3005809810
- 2085947
- 2434839
- 3010707607
- 3006697299
- 3011050570
- 3012507533
- 3008114965
- 9610617
- 3003782610
- 3010202439
- 1833053
- 1221934
- 2936485
- 9680718
- 2020550
- 1421101
- 3014342096
- 3008837339
- 3014644276
- 8043903
- 3008868758
- 3006973663
- 1319480
- 3014279513
- 3015532525
- 9614209
- 1017294
Source Documents#
Other 510(k) Records For Product Code FCW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K131226 | NOVAPROBE LED LIGHT SOURCE | Novaprobe Incorporated | 2014-07-24 |
| K123956 | POWER LED 175 | KARL STORZ Endoscopy-America, Inc. | 2013-01-25 |
| K123359 | OVS1 VIDEO SYSTEM | Olive Medical Corp. | 2012-12-19 |
| K121724 | ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 | Richard Wolf Medical Instruments Corp. | 2012-09-20 |
| K093792 | LED LIGHT SOURCE | Sunoptic Technologies, LLC | 2010-03-18 |
| K091968 | KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C | KARL STORZ Endoscopy-America, Inc. | 2009-09-14 |
| K082813 | STRYKER LED LIGHTSOURCE | Stryker Corp. | 2008-12-19 |
| K081477 | LUXTEC MLX LIGHT SOURCE | Integra Luxtec, Inc. | 2008-06-18 |
| K032430 | ACUEITY MEDICAL LIGHT SOURCE | Acueity, Inc. | 2003-09-05 |
| K012265 | METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 | Circon Video | 2001-10-17 |
| K000229 | VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE | Videolabs, Inc. | 2000-03-21 |
| K993300 | COLDLIGHTSOURCE PL3000 | Fiber Imaging Technologies, Inc. | 1999-11-05 |
| K992447 | 50 W METAL HALIDE ILLUMINATOR, VES 0501. | Angiolaz, Inc. | 1999-10-20 |
| K964586 | PRESCOTT'S LIGHT SOURCE MODEL NO. II-150 | Iba/Griffith | 1997-01-17 |
| K963043 | ENDOSPOT | Corin USA | 1996-09-20 |
Legacy Summary#
summary
FDA Review#
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