METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088
FDA 510(k) clearance K012265 · decided 2001-10-17
Clearance details
- K-number
- K012265
- Device name
- METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088
- Applicant
- Circon Video
- Decision
- Substantially Equivalent
- Date received
- 2001-07-19
- Decision date
- 2001-10-17
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- FCW
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Santa Barbara, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NOVAPROBE LED LIGHT SOURCE (K131226) | Novaprobe Incorporated | 2014-07-24 |
| POWER LED 175 (K123956) | KARL STORZ Endoscopy-America, Inc. | 2013-01-25 |
| OVS1 VIDEO SYSTEM (K123359) | Olive Medical Corp. | 2012-12-19 |
| ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 (K121724) | Richard Wolf Medical Instruments Corp. | 2012-09-20 |
| LED LIGHT SOURCE (K093792) | Sunoptic Technologies, LLC | 2010-03-18 |
| KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C (K091968) | KARL STORZ Endoscopy-America, Inc. | 2009-09-14 |
| STRYKER LED LIGHTSOURCE (K082813) | Stryker Corp. | 2008-12-19 |
| LUXTEC MLX LIGHT SOURCE (K081477) | Integra Luxtec, Inc. | 2008-06-18 |
| ACUEITY MEDICAL LIGHT SOURCE (K032430) | Acueity, Inc. | 2003-09-05 |
| VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE (K000229) | Videolabs, Inc. | 2000-03-21 |
| COLDLIGHTSOURCE PL3000 (K993300) | Fiber Imaging Technologies, Inc. | 1999-11-05 |
| 50 W METAL HALIDE ILLUMINATOR, VES 0501. (K992447) | Angiolaz, Inc. | 1999-10-20 |
Recalls involving this device
No recalls on record reference this clearance.