ENDOSPOT
FDA 510(k) clearance K963043 · decided 1996-09-20
Clearance details
- K-number
- K963043
- Device name
- ENDOSPOT
- Applicant
- Corin USA
- Decision
- Substantially Equivalent
- Date received
- 1996-08-05
- Decision date
- 1996-09-20
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- FCW
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tampa, FL, US
- Third-party review
- No
- Expedited review
- No
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| POWER LED 175 (K123956) | KARL STORZ Endoscopy-America, Inc. | 2013-01-25 |
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| 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 |
| METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 (K012265) | Circon Video | 2001-10-17 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Cormet Hip Resurfacing System (P050016/S012) | Corin USA | 2020-07-17 |
| CORMET HIP RESURFACING SYSTEM (P050016/S011) | Corin USA | 2016-12-21 |
| CORMET HIP RESURFACING SYSTEM (P050016/S010) | Corin USA | 2014-04-03 |
| CORMET HIP RESURFACING SYSTEM (P050016/S009) | Corin USA | 2013-03-22 |
| CORMET HIP RESURFACING SYSTEM (P050016/S008) | Corin USA | 2011-11-10 |
| CORMET HIP RESURFACING SYSTEM (P050016/S007) | Corin USA | 2011-01-13 |
| CORMET HIP RESURFACING SYSTEM (P050016/S006) | Corin USA | 2009-12-31 |
| CORMET HIP RESURFACING SYSTEM (P050016/S005) | Corin USA | 2009-12-03 |