REPROCESSED SCISSOR TIPS
FDA 510(k) clearance K073613 · decided 2008-02-12
Clearance details
- K-number
- K073613
- Device name
- REPROCESSED SCISSOR TIPS
- Applicant
- Sterilmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-12-21
- Decision date
- 2008-02-12
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- NUJ
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and desi recall (Z-1846-2016) | STERILMED, INC. | 2016-05-31 |
| Scissor Tips Model #'s: AESPO888 AESPO889 ENCES0102 MIC3112 MIC3122 MIC3142 MIC3152 SNO89- recall (Z-0570-2009) | Sterilmed Inc | 2009-01-13 |