The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath Endoscopic Articulating Stapler With Sweiveling Cartridge Tip.
| Device ID | K962258 |
| 510k Number | K962258 |
| Device Name: | ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP |
| Classification | Stapler, Surgical |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Melissa Walker, M.s., R.a.c. |
| Correspondent | Melissa Walker, M.s., R.a.c. ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | GAG |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-12 |
| Decision Date | 1996-09-11 |
| Summary: | summary |