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

Dilator, Rectal

21 CFR 876.5450 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FFP is the FDA product code for Dilator, Rectal, a class I device type, regulated under 21 CFR 876.5450. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FFP
Device name
Dilator, Rectal
Regulation
21 CFR 876.5450
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
5
Ingested recalls
0

Clearances, product code FFP

By decision year
5 clearances under product code FFP with a decision year between 1983 and 1997, 1990 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FFP by decision year
YearClearances
19831
19891
19902
19971

Applicants with the most clearances

Product code FFP
Applicants holding the most 510(k) clearances under product code FFP
ApplicantClearances
Cleveland Medical Supply & Services1
Inamed Development Co.1
Mk Conquest Intl., Inc.1
Primrose Medical, Inc.1
TeleMed Systems1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 45 companies shown, in name order