K982212 is an FDA 510(k) clearance for the VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010. This device is classified as a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI).
Submitted by Synergetics, Inc. (St. Charles, US). The FDA issued a Cleared decision on December 2, 1998, 162 days after receiving the submission on June 23, 1998.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K982212 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 23, 1998 |
| Decision Date | December 02, 1998 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GEI — Electrosurgical, Cutting & Coagulation & Accessories |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |