Abc D-Flex Probe
510(k) K151229
Abc D-Flex Probe is a medical device (FDA Class II; FDA product code GEI, Electrosurgical, Cutting & Coagulation & Accessories) made by Conmed Corporation, cleared under FDA 510(k) K151229 on 2 Jun 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK151229 | Date2 Jun 2016 | StatusActive |
Official records
- FDA 510(k) database K151229
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEI
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K151229
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ABC D-FLEX 60-8627-001 | 60-8627-001 / 60-8627-001 | 10653405082507 | — | On the market |
| ABC D-FLEX 60-8727-001 | 60-8727-001 / 60-8727-001 | 10653405082491 | — | No longer on the market |
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