DeviceClearance

Product code NAY— Gastroenterology, Urology

Senhance Surgical System

Classification name
System, Surgical, Computer Controlled Instrument
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
166
First cleared
Most recent

FDA classification 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).”

— U.S. Food and Drug Administration, device classification record for product code NAY under 21 CFR 876.1500, via openFDA

Market context for product code NAY

FDA has cleared 166 devices under product code NAY between 2000 and 2026, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code NAY

Adverse events under product code NAY

product code NAY
Death
433
Injury
7,927
Malfunction
93,790
Other
19
Total
102,169

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code NAY

1–100 of 166

Data sourced from openFDA. This site is unofficial and independent of the FDA.