← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

NAY — System, Surgical, Computer Controlled Instrument

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).

DEVICE CLASS
Class II
REGULATION
21 CFR 876.1500
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
24
510(K)/PMA CLEARANCES
510k: 24
0
RECALL ENTRIES

Recent clearances

K260695Intuitive Surgical · 510k2026-05-22
K254192Asensus Surgical · 510k2026-05-12
K253986Intuitive Surgical, Inc. · 510k2026-03-11
K251739Intuitive Surgical, Inc. · 510k2026-01-16
K253556Intuitive Surgical, Inc. · 510k2026-01-16
K252675Intuitive Surgical, Inc. · 510k2025-12-15
K252069Intuitive Surgical, Inc. · 510k2025-12-02
K251426Intuitive Surgical, Inc. · 510k2025-10-03

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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