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

Fiber, Medical, Absorbent

21 CFR 880.5300 / General Hospital
FDA source (opens on fda.gov)

FRL is the FDA product code for Fiber, Medical, Absorbent, a class I device type, regulated under 21 CFR 880.5300. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
FRL
Device name
Fiber, Medical, Absorbent
Regulation
21 CFR 880.5300
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
19
Ingested recalls
6

Clearances, product code FRL

By decision year
19 clearances under product code FRL with a decision year between 1977 and 2013, 1977 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code FRL by decision year
YearClearances
19775
19781
19793
19803
19812
19911
19931
20061
20111
20131

Applicants with the most clearances

Product code FRL
Applicants holding the most 510(k) clearances under product code FRL
ApplicantClearances
American Hospital Supply4
Medical Engineering Corp.2
Associated Medical Products Co.1
Carapace, Inc.1
Dexide, Inc.1
Icn Pharmaceuticals, Inc.1
Jelco Laboratories1
Medspec Corp.1
Milliken Chemical1
Milliken Healthcare Products, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 370 companies shown, in name order