Panels › Gastroenterology, Urology › Product code FCE · Class 1
Enema Kit
Regulation 876.5210
0510(k)s in 12 months (30 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in FCE
| Company | 510(k)s | Recalls |
|---|---|---|
| The Healthcare Group Laboratories, Inc. | 3 | 0 |
| Plasco, Inc. | 3 | 0 |
| Abco Dealers, Inc. | 2 | 0 |
| Clayton Medical Products, Inc. | 2 | 0 |
| Custom Medical Products, Ltd. | 2 | 0 |
| Orion Life Systems, Inc. | 2 | 0 |
| American Hospital Supply Corp. | 1 | 0 |
| Amsino Intl., Inc. | 1 | 0 |
| Boston Pacific Medical, Inc. | 1 | 0 |
| Carlton Hygienics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 19, 1997 | K974042 | AMSURE CLEANSING ENEMA SET Amsino Intl., Inc. | FCE |
| Aug 26, 1993 | K931896 | PRO-FLO SYSTEM Lafayette Pharmacal, Inc. | FCE |
| Jun 17, 1993 | K922398 | 4 SURE TM ENEMA BAG SET Boston Pacific Medical, Inc. | FCE |
| Nov 1, 1991 | K913620 | ENEMA KIT York County Blind Center | FCE |
| Dec 21, 1990 | K904534 | ENEMA BULB R.A.C., Inc. | FCE |
| Jun 28, 1990 | K901182 | ENEMA BAG SET Orion Life Systems, Inc. | FCE |
| Jun 28, 1990 | K901179 | ENEMA BUCKET SET Orion Life Systems, Inc. | FCE |
| Apr 13, 1990 | K900848 | ENEMA KIT 'STRAIGHT' DESIGN Custom Medical Products, Ltd. | FCE |
| Apr 13, 1990 | K900847 | ENEMA KIT 'Y' DESIGN Custom Medical Products, Ltd. | FCE |
| Jul 28, 1988 | K881218 | GENT-L-KARE CLEANSING ENEMA SET Geneva Laboratories, Inc. | FCE |
| Apr 14, 1988 | K880337 | MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 Plasco, Inc. | FCE |
| Sep 17, 1987 | K872992 | SPS SUSPENSION ENEMA KIT Carolina Medical Products Co. | FCE |
| Apr 1, 1987 | K870796 | MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY Plasco, Inc. | FCE |
| Apr 1, 1987 | K870019 | THE LAHR BALLOON Plasco, Inc. | FCE |
| Apr 22, 1985 | K843792 | VAN JON SUPER CLYSTER(KIT, ENEMA Van Jon Co. | FCE |
| Aug 8, 1984 | K842130 | G.I. CLEANSING KIT Mmi, Inc. | FCE |
| Jan 3, 1984 | K832960 | SHUFFIELD TECH ENEMA TIP Shuffield Tech Co. | FCE |
| Dec 27, 1983 | K833860 | TUCK-TITE COLON FLUID RETAINER Clayton Medical Products, Inc. | FCE |
| May 14, 1980 | K800961 | ENEMA CONTAINER DISP. FOR EMEMA ADMIN. The Healthcare Group Laboratories, Inc. | FCE |
| May 14, 1980 | K800960 | 1500 ML DISPOSABLE ENEMA CONTAINER(1110) The Healthcare Group Laboratories, Inc. | FCE |
| May 14, 1980 | K800959 | LARGE VOLUME ENEMA CONTAINER DISPOSABLE The Healthcare Group Laboratories, Inc. | FCE |
| Oct 2, 1979 | K791863 | MAC LEE ENEMAD Mac Lee Medical Products | FCE |
| Jun 7, 1979 | K790535 | CLAYTON COLON CLEANSING KIT Clayton Medical Products, Inc. | FCE |
| Jan 17, 1979 | K790005 | ADMINISTRATION SET, ENEMA Kelsar Corp. | FCE |
| Aug 14, 1978 | K780877 | ENEMA BAG Abco Dealers, Inc. | FCE |
| Jun 2, 1978 | K780613 | ENEMA, PHOSPHATE Abco Dealers, Inc. | FCE |
| Oct 20, 1977 | K771792 | ENEMA SET Chase Mfg. Co. | FCE |
| Mar 30, 1977 | K770300 | COLON IRRIGATION DEV.,COLON-A-SUN COLONI Sun Product Dist., Inc. | FCE |
| Jan 13, 1977 | K760777 | COLON-X Carlton Hygienics, Inc. | FCE |
| Dec 9, 1976 | K761167 | ENEMA KIT American Hospital Supply Corp. | FCE |
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