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

Gown, Isolation, Surgical

21 CFR 878.4040 / General, Plastic Surgery
FDA source (opens on fda.gov)

FYC is the FDA product code for Gown, Isolation, Surgical, a class II device type, regulated under 21 CFR 878.4040. As of , FDA records hold 68 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
FYC
Device name
Gown, Isolation, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
68
Ingested recalls
2

Clearances, product code FYC

By decision year
68 clearances under product code FYC with a decision year between 1976 and 2024, 2022 the highest year at 10.
Show the numbers
510(k) clearances under FDA product code FYC by decision year
YearClearances
19761
19772
19781
19802
19841
19852
19861
19873
19882
19891
19911
19923
19934
19942
19956
19963
19974
19981
20011
20162
20171
20181
20201
20217
202210
20234
20241

Applicants with the most clearances

Product code FYC
Applicants holding the most 510(k) clearances under product code FYC
ApplicantClearances
American Threshold Industries, Inc.4
American Hospital Supply3
Amsco Sterile Recoveries, Inc.2
Dynatech Medical Products2
Hubei Xinxin Non-woven Co., Ltd2
Kentron Health Care, Inc.2
Medtek Development Corp.2
A Plus International, Inc1
Abco Dealers, Inc.1
Medtronic, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 53 companies shown, in name order