ELECTRODE, FLEXIBLE SUCTION COAGULATOR
FDA 510(k) clearance K130489 · decided 2013-04-19
Clearance details
- K-number
- K130489
- Device name
- ELECTRODE, FLEXIBLE SUCTION COAGULATOR
- Applicant
- Optim, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-02-25
- Decision date
- 2013-04-19
- Days to decision
- 53 days
- Clearance type
- Special
- Product code
- FEH
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Sturbridge, 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 |
|---|---|---|
| PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2 (K122593) | Optim, LLC | 2012-09-13 |
| ACMI BIPOLAR HEMOSTATIC ELECTRODE (K803214) | American Cystocope Makers, Inc. | 1981-01-15 |
Recalls involving this device
No recalls on record reference this clearance.