The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Abcsnare Electrosurgical Probe For Flexible Endoscopes, Model 1336xx.
Device ID | K021079 |
510k Number | K021079 |
Device Name: | ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | CONMED CORP. 14603 E. FREMONT AVE. Centennial, CO 80112 |
Contact | Charles M Hart |
Correspondent | Charles M Hart CONMED CORP. 14603 E. FREMONT AVE. Centennial, CO 80112 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-04-03 |
Decision Date | 2002-07-01 |