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 |