The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Andiodynamics, Inc. Elvs Procedure Kit.
| Device ID | K031233 |
| 510k Number | K031233 |
| Device Name: | ANDIODYNAMICS, INC. ELVS PROCEDURE KIT |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Contact | Teri Juckett |
| Correspondent | Teri Juckett ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-17 |
| Decision Date | 2003-06-18 |