The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Proximate Pph Hemorrhoidal Circular Stapler And Accessories.
| Device ID | K051301 |
| 510k Number | K051301 |
| Device Name: | PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES |
| Classification | Staple, Implantable |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Kimberly Mccoy |
| Correspondent | Kimberly Mccoy 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 | 2005-05-19 |
| Decision Date | 2005-08-30 |
| Summary: | summary |