FDA Product Code
FDA Product Code FCE — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5210
510(k) Clearances — 30 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K974042 | AMSURE CLEANSING ENEMA SET | Amsino Intl., Inc. | 1997-12-19 | Traditional | PDF ↗ |
| K931896 | PRO-FLO SYSTEM | Lafayette Pharmacal, Inc. | 1993-08-26 | Traditional | PDF ↗ |
| K922398 | 4 SURE TM ENEMA BAG SET | Boston Pacific Medical, Inc. | 1993-06-17 | Traditional | PDF ↗ |
| K913620 | ENEMA KIT | York County Blind Center | 1991-11-01 | Traditional | PDF ↗ |
| K904534 | ENEMA BULB | R.A.C., Inc. | 1990-12-21 | Traditional | PDF ↗ |
| K901179 | ENEMA BUCKET SET | Orion Life Systems, Inc. | 1990-06-28 | Traditional | PDF ↗ |
| K901182 | ENEMA BAG SET | Orion Life Systems, Inc. | 1990-06-28 | Traditional | PDF ↗ |
| K900847 | ENEMA KIT 'Y' DESIGN | Custom Medical Products, Ltd. | 1990-04-13 | Traditional | PDF ↗ |
| K900848 | ENEMA KIT 'STRAIGHT' DESIGN | Custom Medical Products, Ltd. | 1990-04-13 | Traditional | PDF ↗ |
| K881218 | GENT-L-KARE CLEANSING ENEMA SET | Geneva Laboratories, Inc. | 1988-07-28 | Traditional | PDF ↗ |
| K880337 | MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 | Plasco, Inc. | 1988-04-14 | Traditional | PDF ↗ |
| K872992 | SPS SUSPENSION ENEMA KIT | Carolina Medical Products Co. | 1987-09-17 | Traditional | PDF ↗ |
| K870796 | MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY | Plasco, Inc. | 1987-04-01 | Traditional | PDF ↗ |
| K870019 | THE LAHR BALLOON | Plasco, Inc. | 1987-04-01 | Traditional | PDF ↗ |
| K843792 | VAN JON SUPER CLYSTER(KIT, ENEMA | Van Jon Co. | 1985-04-22 | Traditional | PDF ↗ |
| K842130 | G.I. CLEANSING KIT | Mmi, Inc. | 1984-08-08 | Traditional | PDF ↗ |
| K832960 | SHUFFIELD TECH ENEMA TIP | Shuffield Tech Co. | 1984-01-03 | Traditional | PDF ↗ |
| K833860 | TUCK-TITE COLON FLUID RETAINER | Clayton Medical Products, Inc. | 1983-12-27 | Traditional | PDF ↗ |
| K800960 | 1500 ML DISPOSABLE ENEMA CONTAINER(1110) | The Healthcare Group Laboratories, Inc. | 1980-05-14 | Traditional | PDF ↗ |
| K800961 | ENEMA CONTAINER DISP. FOR EMEMA ADMIN. | The Healthcare Group Laboratories, Inc. | 1980-05-14 | Traditional | PDF ↗ |
| K800959 | LARGE VOLUME ENEMA CONTAINER DISPOSABLE | The Healthcare Group Laboratories, Inc. | 1980-05-14 | Traditional | PDF ↗ |
| K791863 | MAC LEE ENEMAD | Mac Lee Medical Products | 1979-10-02 | Traditional | PDF ↗ |
| K790535 | CLAYTON COLON CLEANSING KIT | Clayton Medical Products, Inc. | 1979-06-07 | Traditional | PDF ↗ |
| K790005 | ADMINISTRATION SET, ENEMA | Kelsar Corp. | 1979-01-17 | Traditional | PDF ↗ |
| K780877 | ENEMA BAG | Abco Dealers, Inc. | 1978-08-14 | Traditional | PDF ↗ |
| K780613 | ENEMA, PHOSPHATE | Abco Dealers, Inc. | 1978-06-02 | Traditional | PDF ↗ |
| K771792 | ENEMA SET | Chase Mfg. Co. | 1977-10-20 | Traditional | PDF ↗ |
| K770300 | COLON IRRIGATION DEV.,COLON-A-SUN COLONI | Sun Product Dist., Inc. | 1977-03-30 | Traditional | PDF ↗ |
| K760777 | COLON-X | Carlton Hygienics, Inc. | 1977-01-13 | Traditional | PDF ↗ |
| K761167 | ENEMA KIT | American Hospital Supply Corp. | 1976-12-09 | Traditional | PDF ↗ |
Product code FCE · Class I · Gastroenterology, Urology. Data: openFDA.