The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Valutrus Reusable Circular Stapler And Disposable Reloads.
| Device ID | K111195 |
| 510k Number | K111195 |
| Device Name: | VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS |
| Classification | Staple, Implantable |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Dennis Hahn |
| Correspondent | Dennis Hahn ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-28 |
| Decision Date | 2011-08-03 |
| Summary: | summary |