FISCH DRILL IRRIGATOR
FDA 510(k) clearance K861298 · decided 1986-04-23
Clearance details
- K-number
- K861298
- Device name
- FISCH DRILL IRRIGATOR
- Applicant
- Jedmed Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1986-04-07
- Decision date
- 1986-04-23
- Days to decision
- 16 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
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Jedmed Instrument Co.
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.
| Record | Firm | Date |
|---|---|---|
| SINUFLUSH LAVAGE SYSTEM (K131177) | Hedgepath, LLC | 2013-09-20 |
| GM SWIVEL VIDEO (TM) IRRIGATOR (K931398) | Gm Engineering, Inc. | 1993-08-30 |
Recalls involving this device
No recalls on record reference this clearance.