SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES
FDA 510(k) clearance K953453 · decided 1996-01-17
Clearance details
- K-number
- K953453
- Device name
- SYMBIOSIS MONOPOLAR ELECTROSURGICAL ROLLER ELECTRODES
- Applicant
- Symbiosis Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-07-19
- Decision date
- 1996-01-17
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- FAS
- Device class
- 2
- Regulation number
- 876.4300
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Miami, FL, 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 |
|---|
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| Plasma Edge System (K163090) | Chirurgie Innovation | 2017-05-23 |
| Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode (K151976) | Omnitech Systems, Inc. | 2016-06-27 |
| Resection Electrodes (K152092) | Olympus Winter & Ibe GmbH | 2015-10-26 |
| GYRUS AMCI PK BUTTON ELECTRODE (K120567) | Gyrus Acmi, Inc. | 2012-06-20 |
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Recalls involving this device
No recalls on record reference this clearance.