The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiodynamics, Inc. Venacure Nevertouch Direct Procedure Kit.
| Device ID | K112600 |
| 510k Number | K112600 |
| Device Name: | ANGIODYNAMICS, INC. VENACURE NEVERTOUCH DIRECT 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 | 2011-09-07 |
| Decision Date | 2012-01-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787114030130 | K112600 | 000 |
| H787114020020 | K112600 | 000 |
| H787114030010 | K112600 | 000 |
| H787114030020 | K112600 | 000 |
| H787114030030 | K112600 | 000 |
| H787114030040 | K112600 | 000 |
| H787114030050 | K112600 | 000 |
| H787114030060 | K112600 | 000 |
| H787114030070 | K112600 | 000 |
| H787114030120 | K112600 | 000 |
| H787114020010 | K112600 | 000 |