PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES
FDA 510(k) clearance K994151 · decided 2000-03-01
Clearance details
- K-number
- K994151
- Device name
- PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES
- Applicant
- Ximed/Prosure/Injectx
- Decision
- Substantially Equivalent
- Date received
- 1999-12-09
- Decision date
- 2000-03-01
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- GAA
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.