K182371 is an FDA 510(k) clearance for the da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories. This device is classified as a System, Surgical, Computer Controlled Instrument (Class II - Special Controls, product code NAY).
Submitted by Intuitive Surgical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 14, 2019, 195 days after receiving the submission on August 31, 2018.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 876.1500. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K182371 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | August 31, 2018 |
| Decision Date | March 14, 2019 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | NAY — System, Surgical, Computer Controlled Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |