The following data is part of a premarket notification filed by Katalyst Surgical, Llc with the FDA for Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps.
Device ID | K213610 |
510k Number | K213610 |
Device Name: | Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | Katalyst Surgical, LLC 754 Goddard Ave Chesterfield, MO 63005 |
Contact | Liz Morgan |
Correspondent | Liz Morgan Katalyst Surgical, LLC 754 Goddard Ave Chesterfield, MO 63005 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-11-15 |
Decision Date | 2022-10-07 |