ACMI BIPOLAR HEMOSTATIC ELECTRODE
FDA 510(k) clearance K803214 · decided 1981-01-15
Clearance details
- K-number
- K803214
- Device name
- ACMI BIPOLAR HEMOSTATIC ELECTRODE
- Applicant
- American Cystocope Makers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-12-18
- Decision date
- 1981-01-15
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- FEH
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| ELECTRODE, FLEXIBLE SUCTION COAGULATOR (K130489) | Optim, LLC | 2013-04-19 |
| PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 (K122593) | Optim, LLC | 2012-09-13 |
Recalls involving this device
No recalls on record reference this clearance.