SHAH SELF-CLEARING MASTOID SUCTION TUBE
FDA 510(k) clearance K853589 · decided 1985-12-23
Clearance details
- K-number
- K853589
- Device name
- SHAH SELF-CLEARING MASTOID SUCTION TUBE
- Applicant
- Downs Surgical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-27
- Decision date
- 1985-12-23
- Days to decision
- 118 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
- Wilmington, MA, 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 |
|---|---|---|
| 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 |
| MICRO FLUID APPLICATOR (K841357) | Treace Medical, Inc. | 1984-08-24 |
| RIGID SUCTION TIPS & RELATED ITEMS (K822010) | Kelleher Corp. | 1982-08-12 |
Recalls involving this device
No recalls on record reference this clearance.