Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102
FDA 510(k) clearance K162218 · decided 2016-11-22
Clearance details
- K-number
- K162218
- Device name
- Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102
- Applicant
- Nuance Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-08-08
- Decision date
- 2016-11-22
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- MLY
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Nuance Medical
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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.