The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Reusable Pph Circular Stapler Handle, Pph Circular Stapler Reload & Accessory Set.
| Device ID | K103672 |
| 510k Number | K103672 |
| Device Name: | REUSABLE PPH CIRCULAR STAPLER HANDLE, PPH CIRCULAR STAPLER RELOAD & ACCESSORY SET |
| Classification | Staple, Implantable |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | Dennis Hahn |
| Correspondent | Dennis Hahn 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 | 2010-12-16 |
| Decision Date | 2011-04-08 |
| Summary: | summary |