The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Echelon Circular Powered Stapler.
Device ID | K163523 |
510k Number | K163523 |
Device Name: | ECHELON CIRCULAR Powered Stapler |
Classification | Staple, Implantable |
Applicant | Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969 |
Contact | Carmen Ortiz |
Correspondent | Rubina Dosani Ethicon Endo-Surgery, LLC 4545 Creek Road Cincinnati, OH 45242 |
Product Code | GDW |
CFR Regulation Number | 878.4750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-12-15 |
Decision Date | 2017-04-18 |
Summary: | summary |