GM SWIVEL VIDEO (TM) IRRIGATOR
FDA 510(k) clearance K931398 · decided 1993-08-30
Clearance details
- K-number
- K931398
- Device name
- GM SWIVEL VIDEO (TM) IRRIGATOR
- Applicant
- Gm Engineering, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-03-19
- Decision date
- 1993-08-30
- Days to decision
- 164 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
- La Verne, CA, 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 |
|---|---|---|
| SINUFLUSH LAVAGE SYSTEM (K131177) | Hedgepath, LLC | 2013-09-20 |
| FISCH DRILL IRRIGATOR (K861298) | Jedmed Instrument Co. | 1986-04-23 |
Recalls involving this device
No recalls on record reference this clearance.