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

Needle, Gastro-Urology

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

FHR is the FDA product code for Needle, Gastro-Urology, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
FHR
Device name
Needle, Gastro-Urology
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
1
Ingested recalls
0

Clearances, product code FHR

By decision year
1 clearance under product code FHR with a decision year between 1981 and 1981, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FHR by decision year
YearClearances
19811

Applicants with the most clearances

Product code FHR
Applicants holding the most 510(k) clearances under product code FHR
ApplicantClearances
Visitec Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order