The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Endopath Electrosurgery Probe Plus Ii.
Device ID | K180031 |
510k Number | K180031 |
Device Name: | Endopath Electrosurgery Probe Plus II |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969 |
Contact | Carmen Ortiz |
Correspondent | David Locke Ethicon Endo-Surgery, LLC 4545 Creek Road Cincinnati, OH 45242 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-01-04 |
Decision Date | 2018-05-07 |
Summary: | summary |