ASLAN KNOT PUSHER
FDA 510(k) clearance K950924 · decided 1995-03-14
Clearance details
- K-number
- K950924
- Device name
- ASLAN KNOT PUSHER
- Applicant
- Aslan Medical Technologies, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-01
- Decision date
- 1995-03-14
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- FDE
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Kalamazoo, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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|---|---|---|
| ENDOSCOPE INTRODUCER KIT (K955717) | Mitsubishi Cable America, Inc. | 1996-04-18 |
| 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.