FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
REPROCESSED HARMONIC SCALPELS
K Number: K050343
·
Decision Apr 12, 2005
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
25
Applicant Total
59
Review Days
60
Basic Information
- Device Name
- REPROCESSED HARMONIC SCALPELS
- K Number
- K050343
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- STERILMED, INC.
- Date Received
- February 11, 2005
- Decision Date
- April 12, 2005
- Product Code
- NLQ
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NLQ | Single-Use Reprocessed Ultrasonic Surgical Instruments | FDA unclassified | Unknown |
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| K132566 | REPROCESSED HARMONIC SHEAR | Jun 14, 2014 | Substantially Equivalent |
| K133414 | REPROCESSED CLOSURE SYSTEM | Jan 22, 2014 | Substantially Equivalent |
| K123096 | REPROCESSED VESSEL SEALER | Jan 25, 2013 | Substantially Equivalent |