CANDELA INTRODUCER SHEATH SYSTEM
FDA 510(k) clearance K912443 · decided 1991-08-16
Clearance details
- K-number
- K912443
- Device name
- CANDELA INTRODUCER SHEATH SYSTEM
- Applicant
- Candela Laser Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-06-03
- Decision date
- 1991-08-16
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- FDE
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Wayland, 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 |
|---|---|---|
| ENDOSCOPE INTRODUCER KIT (K955717) | Mitsubishi Cable America, Inc. | 1996-04-18 |
| ASLAN KNOT PUSHER (K950924) | Aslan Medical Technologies, Ltd. | 1995-03-14 |
| GEENEN/ZEBRA GUIDELINES (K942677) | Boston Scientific Corp | 1994-07-21 |
Recalls involving this device
No recalls on record reference this clearance.