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

Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

21 CFR 876.4300 / Gastroenterology, Urology
FDA source (opens on fda.gov)

KNS is the FDA product code for Unit, Electrosurgical, Endoscopic (With Or Without Accessories), a class II device type, regulated under 21 CFR 876.4300. As of , FDA records hold 188 510(k) clearances under this code, the most recent dated , and 121 recalls.

Classification record

Product code
KNS
Device name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Regulation
21 CFR 876.4300
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
Yes
Ingested clearances
189
Ingested recalls
125

Clearances, product code KNS

By decision year
189 clearances under product code KNS with a decision year between 1976 and 2026, 2025 the highest year at 11.
Show the numbers
510(k) clearances under FDA product code KNS by decision year
YearClearances
19761
19771
19782
19808
19812
19825
19841
19856
19865
19871
19882
19897
19907
19916
19923
19946
19955
19967
19976
19983
19999
20003
20016
20022
20035
20042
20053
20061
20071
20083
20093
20104
20111
20122
20132
20141
20153
20163
20173
20185
20197
20204
20214
20223
20239
20243
202511
20262

Applicants with the most clearances

Product code KNS
Applicants holding the most 510(k) clearances under product code KNS
ApplicantClearances
Boston Scientific Corporation17
Wilson-Cook Medical Inc.12
Olympus Medical Systems Corp.10
Aqua Medical, Inc.5
Medtronic, Inc.5
Creo Medical Ltd5
Mr Associates, Inc.5
Circon Acmi4
Everest Medical Corp.4
Gyrus ACMI, Inc.4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 94 companies shown, in name order