The following data is part of a premarket notification filed by Lydus Medical Ltd. with the FDA for Vesseal.
| Device ID | K221280 |
| 510k Number | K221280 |
| Device Name: | Vesseal |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | Lydus Medical Ltd. 13 Zarhin St. Ra'anana, IL 4366241 |
| Contact | Jessica Weiss |
| Correspondent | Orly Maor Orly Maor 25 Sirkin Street Kfar Saba, IL 4442156 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-03 |
| Decision Date | 2022-12-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VESSEAL 75796556 not registered Dead/Abandoned |
Heuser, Richard R. 1999-09-10 |
![]() VESSEAL 73586029 1475597 Dead/Cancelled |
T J SMITH AND NEPHEW, LIMITED 1986-02-28 |