ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145
FDA 510(k) clearance K012176 · decided 2001-10-01
Clearance details
- K-number
- K012176
- Device name
- ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145
- Applicant
- Ethicon Endo-Surgery, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-12
- Decision date
- 2001-10-01
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- LFL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.