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

Enema Kit

21 CFR 876.5210 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FCE is the FDA product code for Enema Kit, a class I device type, regulated under 21 CFR 876.5210. FDA's definition for this code reads: "This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket...". As of , FDA records hold 30 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FCE
Device name
Enema Kit
FDA definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Regulation
21 CFR 876.5210
Device class
Class I
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
30
Ingested recalls
0

Clearances, product code FCE

By decision year
30 clearances under product code FCE with a decision year between 1976 and 1997, 1990 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code FCE by decision year
YearClearances
19761
19773
19782
19793
19803
19831
19842
19851
19873
19882
19905
19911
19932
19971

Applicants with the most clearances

Product code FCE
Applicants holding the most 510(k) clearances under product code FCE
ApplicantClearances
Plasco, Inc.3
The Healthcare Group Laboratories, Inc.3
Abco Dealers, Inc.2
Clayton Medical Products, Inc.2
Custom Medical Products, Ltd.2
Orion Life Systems, Inc.2
American Hospital Supply1
Amsino Intl., Inc.1
Boston Pacific Medical, Inc.1
Carlton Hygienics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 67 companies shown, in name order