RIGID SUCTION TIPS & RELATED ITEMS
FDA 510(k) clearance K822010 · decided 1982-08-12
Clearance details
- K-number
- K822010
- Device name
- RIGID SUCTION TIPS & RELATED ITEMS
- Applicant
- Kelleher Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-07-08
- Decision date
- 1982-08-12
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- JZF
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Kelleher Corp.
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 |
|---|---|---|
| EXMOOR TYMPANOCENTESIS KIT (TK/1) (K973587) | Exmoor Plastics , Ltd. | 1998-01-23 |
| MIDDLE EAR VIEWER AND FLUID COLLECTOR (K862903) | Steven K. Juhn | 1986-11-24 |
| SHAH SELF-CLEARING MASTOID SUCTION TUBE (K853589) | Downs Surgical , Ltd. | 1985-12-23 |
| MICRO FLUID APPLICATOR (K841357) | Treace Medical, Inc. | 1984-08-24 |
Recalls involving this device
No recalls on record reference this clearance.