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

Ring (Wound Protector), Drape Retention, Internal

21 CFR 878.4370 / General, Plastic Surgery
FDA source (opens on fda.gov)

KGW is the FDA product code for Ring (Wound Protector), Drape Retention, Internal, a class II device type, regulated under 21 CFR 878.4370. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KGW
Device name
Ring (Wound Protector), Drape Retention, Internal
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
0

Clearances, product code KGW

By decision year
9 clearances under product code KGW with a decision year between 1979 and 2026, 2026 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KGW by decision year
YearClearances
19791
19841
20041
20071
20091
20101
20131
20262

Applicants with the most clearances

Product code KGW
Applicants holding the most 510(k) clearances under product code KGW
ApplicantClearances
Applied Medical Resources Corp7
Gainor Medical1
Surgikos, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order