FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105
K Number: K994280
·
Decision Mar 17, 2000
Classifications
1
FEI Numbers
138
Registration Numbers
138
Same Product Code
155
Applicant Total
111
Review Days
88
Basic Information
- Device Name
- ULTRACISION HARMONIC SCALPEL SHARP CURVED BLADE/FAST BLADE, MODEL HF105
- K Number
- K994280
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ETHICON ENDO-SURGERY, INC.
- Date Received
- December 20, 1999
- Decision Date
- March 17, 2000
- Product Code
- LFL
- 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 |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | FDA unclassified | Unknown |
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