SINUFLUSH LAVAGE SYSTEM
FDA 510(k) clearance K131177 · decided 2013-09-20
Clearance details
- K-number
- K131177
- Device name
- SINUFLUSH LAVAGE SYSTEM
- Applicant
- Hedgepath, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-04-25
- Decision date
- 2013-09-20
- Days to decision
- 148 days
- Clearance type
- Traditional
- Product code
- KAR
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Tampa, FL, 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 |
|---|---|---|
| GM SWIVEL VIDEO (TM) IRRIGATOR (K931398) | Gm Engineering, Inc. | 1993-08-30 |
| FISCH DRILL IRRIGATOR (K861298) | Jedmed Instrument Co. | 1986-04-23 |
Recalls involving this device
No recalls on record reference this clearance.