The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath Sureseal Reducer Cap.
| Device ID | K001220 |
| 510k Number | K001220 |
| Device Name: | ENDOPATH SURESEAL REDUCER CAP |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Tamima Itani |
| Correspondent | Tamima Itani ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-17 |
| Decision Date | 2000-05-16 |