ENDOSCOPE INTRODUCER KIT
FDA 510(k) clearance K955717 · decided 1996-04-18
Clearance details
- K-number
- K955717
- Device name
- ENDOSCOPE INTRODUCER KIT
- Applicant
- Mitsubishi Cable America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-12-18
- Decision date
- 1996-04-18
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- FDE
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Villa Park, 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 |
|---|---|---|
| ASLAN KNOT PUSHER (K950924) | Aslan Medical Technologies, Ltd. | 1995-03-14 |
| GEENEN/ZEBRA GUIDELINES (K942677) | Boston Scientific Corp | 1994-07-21 |
| CANDELA INTRODUCER SHEATH SYSTEM (K912443) | Candela Laser Corp. | 1991-08-16 |
Recalls involving this device
No recalls on record reference this clearance.