REPROCESSED HARMONIC SCALPELS
FDA 510(k) clearance K050343 · decided 2005-04-12
Clearance details
- K-number
- K050343
- Device name
- REPROCESSED HARMONIC SCALPELS
- Applicant
- Sterilmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-02-11
- Decision date
- 2005-04-12
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- NLQ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Maple Grove, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Biopsy Forceps, Hot Model #'s: BAL60110 BAR000852 BAR000854 and MIC1550 Laparoscopic elect recall (Z-0549-2009) | Sterilmed Inc | 2009-01-13 |
| Harmonic Scalpel Model #'s: ETHACE14S ETHACE23P ETHACE36P ETHCS14C ETHFCS9 ETHHDH05 ETHLCS recall (Z-0559-2009) | Sterilmed Inc | 2009-01-13 |