AMBIT TUNNELER
FDA 510(k) clearance K110814 · decided 2011-04-08
Clearance details
- K-number
- K110814
- Device name
- AMBIT TUNNELER
- Applicant
- Summit Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-03-24
- Decision date
- 2011-04-08
- Days to decision
- 15 days
- Clearance type
- Abbreviated
- Product code
- BSO
- Device class
- 2
- Regulation number
- 868.5120
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Salt Lake City, UT, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.