The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath Optical Access Needkle.
| Device ID | K951444 |
| 510k Number | K951444 |
| Device Name: | ENDOPATH OPTICAL ACCESS NEEDKLE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Lorri Jones |
| Correspondent | Lorri Jones ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-29 |
| Decision Date | 1995-04-25 |