REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE
FDA 510(k) clearance DEN130046 · decided 2015-03-06
Clearance details
- K-number
- DEN130046
- Device name
- REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPHINCTER ASSIST DEVICE
- Applicant
- Somna Therapeutics, LLC
- Decision
- Unknown
- Date received
- 2013-11-14
- Decision date
- 2015-03-06
- Days to decision
- 477 days
- Clearance type
- Direct
- Product code
- PKA
- Device class
- 2
- Regulation number
- 874.5900
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Germantown, WI, 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.
| Record | Firm | Date |
|---|---|---|
| Reza Band, Reflux Band (K173934) | Somna Therapeutics, LLC | 2018-04-13 |
Recalls involving this device
No recalls on record reference this clearance.