510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NAYClass II

System, Surgical, Computer Controlled Instrument

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NAY is the FDA product code for System, Surgical, Computer Controlled Instrument, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "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)". As of , FDA records hold 165 510(k) clearances under this code, the most recent dated , and 248 recalls.

Classification record

Product code
NAY
Device name
System, Surgical, Computer Controlled Instrument
FDA 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).
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
166
Ingested recalls
248

Clearances, product code NAY

By decision year
166 clearances under product code NAY with a decision year between 2000 and 2026, 2017 the highest year at 16.
Show the numbers
510(k) clearances under FDA product code NAY by decision year
YearClearances
20001
20014
20023
20031
20044
20054
20063
20084
20093
20101
20117
20124
20134
20149
20153
20168
201716
201815
20198
20209
202111
20226
20235
202410
202516
20267

Applicants with the most clearances

Product code NAY
Applicants holding the most 510(k) clearances under product code NAY
ApplicantClearances
Intuitive Surgical, Inc.146
Asensus Surgical, Inc.15
AKTORmed GmbH2
Computer Motion, Inc.2
Intuitive Surgical, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 75 companies shown, in name order