LIGHT SOURCE, ENDOSCOP, XENON ARC
FDA 510(k) clearance K890448 · decided 1989-05-08
Clearance details
- K-number
- K890448
- Device name
- LIGHT SOURCE, ENDOSCOP, XENON ARC
- Applicant
- Mira, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-01-27
- Decision date
- 1989-05-08
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- FFS
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Waltham, MA, 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 |
|---|---|---|
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| TRU-CABLE (K063309) | Truphatek International, Ltd. | 2007-01-12 |
| ACCUTECH ENDOLITE PROBE (K061025) | Accutech Medical Technologies, Inc. | 2006-05-31 |
| SOVIS OPTIQUE'S ENDOSCOPIC CABLE (K023633) | Sovis Optique | 2002-12-31 |
| MICRO LINK ENDOSCOPIC FIBER CABLE, MODEL B1-90159 (K001698) | Cogent Light Technologies, Inc. | 2000-07-17 |
| SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES (K994084) | Smith & Nephew, Inc. | 2000-01-20 |
| SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR (K991323) | Smith & Nephew, Inc. | 1999-07-06 |
| SOLARTEC SOURCE 270, MODEL # 90123 (K983714) | Cogent Light Technologies, Inc. | 1998-12-23 |
| FIBER OPTIC ENDOILLUMINATION PROBE (K982462) | Microvision, Inc. | 1998-09-14 |
| FIBER OPTIC ENDOILLUMINATION PROBE (K980636) | Dutch Ophthalmic USA, Inc. | 1998-05-20 |
| VISTA ILLUMINATION SYSTEM (K970217) | Vista Medical Technologies, Inc. | 1997-04-02 |
Recalls involving this device
No recalls on record reference this clearance.