K213831 is an FDA 510(k) clearance for the Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Gyrus Acmi, Inc. (Westborough, US). The FDA issued a Cleared decision on January 4, 2022, 27 days after receiving the submission on December 8, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K213831 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 08, 2021 |
| Decision Date | January 04, 2022 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| 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). |