The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Ligasure Vessel Sealing System.
| Device ID | K981916 |
| 510k Number | K981916 |
| Device Name: | LIGASURE VESSEL SEALING SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder, CO 80301 |
| Contact | Charles Copperberg |
| Correspondent | Charles Copperberg VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder, CO 80301 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-01 |
| Decision Date | 1998-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884524001685 | K981916 | 000 |
| 10884521037199 | K981916 | 000 |
| 10884521175525 | K981916 | 000 |
| 10884524002712 | K981916 | 000 |
| 10884521546219 | K981916 | 000 |
| 20884524000647 | K981916 | 000 |
| 10884524001692 | K981916 | 000 |
| 10884524002132 | K981916 | 000 |
| 10884524002309 | K981916 | 000 |
| 10884524002705 | K981916 | 000 |
| 10884524002767 | K981916 | 000 |
| 10884524002965 | K981916 | 000 |
| 10884521175549 | K981916 | 000 |
| 20884524000289 | K981916 | 000 |
| 20884524002153 | K981916 | 000 |
| 20884524002511 | K981916 | 000 |
| 10884521038486 | K981916 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LIGASURE VESSEL SEALING SYSTEM 76413160 2763674 Dead/Cancelled |
COVIDIEN AG 2002-05-29 |