K212511 is an FDA 510(k) clearance for the 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110), a Laparoscope, General & Plastic Surgery (Class II — Special Controls, product code GCJ), submitted by Stryker (San Jose, US). The FDA issued a Cleared decision on November 4, 2021, 86 days after receiving the submission on August 10, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K212511 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 10, 2021 |
| Decision Date | November 04, 2021 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GCJ — Laparoscope, General & Plastic Surgery |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| 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). |