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

Hemostat

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

HRQ is the FDA product code for Hemostat, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
HRQ
Device name
Hemostat
Regulation
21 CFR 878.4800
Device class
Class I
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
15
Ingested recalls
3

Clearances, product code HRQ

By decision year
15 clearances under product code HRQ with a decision year between 1982 and 1992, 1984 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code HRQ by decision year
YearClearances
19823
19832
19844
19861
19882
19892
19921

Applicants with the most clearances

Product code HRQ
Applicants holding the most 510(k) clearances under product code HRQ
ApplicantClearances
Scanlan Intl., Inc.3
Applied Medical Technologies1
Disposable Sterile Surgical Instruments, Inc.1
Falcon Instruments, Inc.1
Far East Intl. Trading Corp.1
I M, Inc.1
I M, Inc.1
Imm Enterprises, Ltd.1
Kelleher Corp.1
Kinetic Medical Products1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 177 companies shown, in name order