The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Ethicon Endo-surgery Rotating Hook Knife, Model In2508.
| Device ID | K091290 |
| 510k Number | K091290 |
| Device Name: | ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Tom Bosticco |
| Correspondent | Tom Bosticco 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 | 2009-05-01 |
| Decision Date | 2009-10-29 |
| Summary: | summary |