1 device · 1 company · 2018
Product code NAY: System, Surgical, Computer Controlled Instrument
1 device under product code NAY, 2018, from 1 company. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (1 of 1 here), the regulation, and MAUDE report counts by product code.
System, Surgical, Computer Controlled Instrument. 21 CFR 876.1500, Class II. 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). MAUDE held 143,880 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| TransEnterix Senhance Surgical SystemK180163 · 510(k) | TransEnterix, Inc. | Gastroenterology-Urology | database entry |
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