FCE — Enema Kit Class I
Classification Details
- Product Code
- FCE
- Device Class
- Class I
- Regulation Number
- 876.5210
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K974042 | amsino intl | AMSURE CLEANSING ENEMA SET | December 19, 1997 |
| K931896 | lafayette pharmacal | PRO-FLO SYSTEM | August 26, 1993 |
| K922398 | boston pacific medical | 4 SURE TM ENEMA BAG SET | June 17, 1993 |
| K913620 | york county blind center | ENEMA KIT | November 1, 1991 |
| K904534 | r.a.c | ENEMA BULB | December 21, 1990 |
| K901182 | orion life systems | ENEMA BAG SET | June 28, 1990 |
| K901179 | orion life systems | ENEMA BUCKET SET | June 28, 1990 |
| K900847 | custom medical products | ENEMA KIT 'Y' DESIGN | April 13, 1990 |
| K900848 | custom medical products | ENEMA KIT 'STRAIGHT' DESIGN | April 13, 1990 |
| K881218 | geneva laboratories | GENT-L-KARE CLEANSING ENEMA SET | July 28, 1988 |
| K880337 | plasco | MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 | April 14, 1988 |
| K872992 | carolina medical products | SPS SUSPENSION ENEMA KIT | September 17, 1987 |
| K870796 | plasco | MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY | April 1, 1987 |
| K870019 | plasco | THE LAHR BALLOON | April 1, 1987 |
| K843792 | van jon | VAN JON SUPER CLYSTER(KIT, ENEMA | April 22, 1985 |
| K842130 | mmi | G.I. CLEANSING KIT | August 8, 1984 |
| K832960 | shuffield tech | SHUFFIELD TECH ENEMA TIP | January 3, 1984 |
| K833860 | clayton medical products | TUCK-TITE COLON FLUID RETAINER | December 27, 1983 |
| K800961 | healthcare group laboratories | ENEMA CONTAINER DISP. FOR EMEMA ADMIN. | May 14, 1980 |
| K800959 | healthcare group laboratories | LARGE VOLUME ENEMA CONTAINER DISPOSABLE | May 14, 1980 |