The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Ethicon Endo-surgery Rotating Endoscopic Scissors, Model In2507.
Device ID | K091824 |
510k Number | K091824 |
Device Name: | ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507 |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
Contact | Glenda Marsh |
Correspondent | Glenda Marsh ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-06-19 |
Decision Date | 2009-11-27 |
Summary: | summary |