The following data is part of a premarket notification filed by Richard Wolf Medical Instruments Corporation with the FDA for Tipcontrol Rf Instrument Bipo Ø 2.5mm Wl 280mm, Tipcontrol Rf Instrument Bipo Ø 2.5mm Wl 350mm.
| Device ID | K170377 |
| 510k Number | K170377 |
| Device Name: | TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 280MM, TipControl RF INSTRUMENT BIPO Ø 2.5MM WL 350MM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL 60061 |
| Contact | Mike Loiterman |
| Correspondent | Mike Loiterman Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL 60061 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-07 |
| Decision Date | 2017-04-05 |
| Summary: | summary |