The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath Optiview Optical Surgical Obturator And Sleeve.
| Device ID | K972578 |
| 510k Number | K972578 |
| Device Name: | ENDOPATH OPTIVIEW OPTICAL SURGICAL OBTURATOR AND SLEEVE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Ivan S Placko |
| Correspondent | Ivan S Placko 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 | 1997-07-10 |
| Decision Date | 1997-10-01 |
| Summary: | summary |