The following data is part of a premarket notification filed by Katalyst Surgical, Llc with the FDA for Kogent Bipolar Forceps.
| Device ID | K123172 |
| 510k Number | K123172 |
| Device Name: | KOGENT BIPOLAR FORCEPS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | KATALYST SURGICAL, LLC 754 Goddard Ave Chesterfield, MO 63005 |
| Contact | Mona Dean |
| Correspondent | Mona Dean 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 | 2012-10-09 |
| Decision Date | 2012-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817489024126 | K123172 | 000 |
| 00856312006212 | K123172 | 000 |
| 00856312006229 | K123172 | 000 |
| 00856312006236 | K123172 | 000 |
| 00856312006243 | K123172 | 000 |
| 00856312006250 | K123172 | 000 |
| 00856312006267 | K123172 | 000 |
| 00856312006274 | K123172 | 000 |
| 00856312006281 | K123172 | 000 |
| 00856312006205 | K123172 | 000 |
| 00856312006199 | K123172 | 000 |
| 00856312006113 | K123172 | 000 |
| 00856312006120 | K123172 | 000 |
| 00856312006137 | K123172 | 000 |
| 00856312006144 | K123172 | 000 |
| 00856312006151 | K123172 | 000 |
| 00856312006168 | K123172 | 000 |
| 00856312006175 | K123172 | 000 |
| 00856312006182 | K123172 | 000 |
| 00856312006915 | K123172 | 000 |
| 00856312006922 | K123172 | 000 |
| 00817489024041 | K123172 | 000 |
| 00817489024058 | K123172 | 000 |
| 00817489024065 | K123172 | 000 |
| 00817489024072 | K123172 | 000 |
| 00817489024089 | K123172 | 000 |
| 00817489024096 | K123172 | 000 |
| 00817489024102 | K123172 | 000 |
| 00817489024119 | K123172 | 000 |
| 00817489024034 | K123172 | 000 |
| 00817489024027 | K123172 | 000 |
| 00856312006939 | K123172 | 000 |
| 00817489023952 | K123172 | 000 |
| 00817489023969 | K123172 | 000 |
| 00817489023976 | K123172 | 000 |
| 00817489023983 | K123172 | 000 |
| 00817489023990 | K123172 | 000 |
| 00817489024003 | K123172 | 000 |
| 00817489024010 | K123172 | 000 |
| 00856312006106 | K123172 | 000 |