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

Clamp, Umbilical

21 CFR 884.4530 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HFW is the FDA product code for Clamp, Umbilical, a class II device type, regulated under 21 CFR 884.4530. As of , FDA records hold 36 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
HFW
Device name
Clamp, Umbilical
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
36
Ingested recalls
1

Clearances, product code HFW

By decision year
36 clearances under product code HFW with a decision year between 1978 and 2004, 1997 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code HFW by decision year
YearClearances
19781
19862
19872
19881
19892
19902
19911
19923
19931
19942
19952
19974
19992
20003
20014
20022
20042

Applicants with the most clearances

Product code HFW
Applicants holding the most 510(k) clearances under product code HFW
ApplicantClearances
Maternus, Inc.3
Precision Dynamics Corporation3
Busse Hospital Disposables2
Hollister, Inc.2
Alpha Unlimited, Inc.1
Andermac, Inc.1
Balagan Medical, Inc.1
Dynarex Corp.1
Gam Industries, Inc.1
Gps1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 51 companies shown, in name order