The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Endopath Disposable Thoracic Trocar Sleeve.
| Device ID | K920110 |
| 510k Number | K920110 |
| Device Name: | ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE |
| Classification | Cannula, Surgical, General & Plastic Surgery |
| Applicant | ETHICON, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Sandra Diggs |
| Correspondent | Sandra Diggs ETHICON, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | GEA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-07 |
| Decision Date | 1992-04-02 |