The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Ethicon Endo Surgery Articulating Snare.
Device ID | K073288 |
510k Number | K073288 |
Device Name: | ETHICON ENDO SURGERY ARTICULATING SNARE |
Classification | Snare, Flexible |
Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
Contact | Glenda C Marsh |
Correspondent | Glenda C Marsh ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
Product Code | FDI |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-11-21 |
Decision Date | 2008-06-12 |
Summary: | summary |