OP-CON SURGICAL INSTRUMENT #9
FDA 510(k) clearance K834169 · decided 1984-01-17
Clearance details
- K-number
- K834169
- Device name
- OP-CON SURGICAL INSTRUMENT #9
- Applicant
- Imm Enterprises , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1983-11-21
- Decision date
- 1984-01-17
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- BWB
- Device class
- 1
- Regulation number
- 868.5780
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Imm Enterprises
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 |
|---|---|---|
| TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS (K884584) | Eastmed Enterprises, Inc. | 1988-11-14 |
| ROVENSTEIN FORCEPS (K880318) | Eastmed Enterprises, Inc. | 1988-03-21 |
| MAGILL FORCEPS (K880319) | Eastmed Enterprises, Inc. | 1988-03-21 |
| CAT. 9 ANESTHESIOLOGY RESPIRATORY DEV (K840313) | Imm Enterprises , Ltd. | 1984-02-04 |
| INTRODUCER FOR ENDOTRACHEAL TUBE (K820451) | Imed Corp. | 1982-03-26 |
Recalls involving this device
No recalls on record reference this clearance.