The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath Optical Obturator And Sleeve.
| Device ID | K941027 |
| 510k Number | K941027 |
| Device Name: | ENDOPATH OPTICAL OBTURATOR AND SLEEVE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Claudia L Berner |
| Correspondent | Claudia L Berner 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 | 1994-03-04 |
| Decision Date | 1994-08-23 |