SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
FDA 510(k) clearance K133316 · decided 2014-05-28
Clearance details
- K-number
- K133316
- Device name
- SPIROL BLOCK (19 GA. OPEN END MODELS), (20 GA. OPEN END MODELS), (19 GA. CLOSED END MODELS), (20 GA. CLOSED END MODELS)
- Applicant
- Epimed International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-10-28
- Decision date
- 2014-05-28
- Days to decision
- 212 days
- Clearance type
- Traditional
- Product code
- BSO
- Device class
- 2
- Regulation number
- 868.5120
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Johnstown, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.