VASCUCLEAR PRECISION BIPOLAR
FDA 510(k) clearance K102983 · decided 2010-11-01
Clearance details
- K-number
- K102983
- Device name
- VASCUCLEAR PRECISION BIPOLAR
- Applicant
- Sorin Group USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-10-07
- Decision date
- 2010-11-01
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Arvada, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MICRO YAG ND:YAG LASER SYSTEM (P850063/S001) | Sorin Group USA, Inc. | 1986-06-17 |
| MICRO YAG ND:YAG LASER SYSTEM (P850063) | Sorin Group USA, Inc. | 1986-01-31 |