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

Holder, Needle, Gastroenterologic

21 CFR 876.4730 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FHQ is the FDA product code for Holder, Needle, Gastroenterologic, a class I device type, regulated under 21 CFR 876.4730. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
FHQ
Device name
Holder, Needle, Gastroenterologic
Regulation
21 CFR 876.4730
Device class
Class I
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
4

Clearances, product code FHQ

By decision year
7 clearances under product code FHQ with a decision year between 1977 and 1998, 1993 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code FHQ by decision year
YearClearances
19771
19852
19933
19981

Applicants with the most clearances

Product code FHQ
Applicants holding the most 510(k) clearances under product code FHQ
ApplicantClearances
Artiberia2
Edward Weck, Inc.1
Holmed LLC1
Nusurg, Inc.1
Phx Technologies Corp.1
Retrax1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 324 companies shown, in name order