1500 Ml Disposable Enema Container(1110)

K800960 is the FDA 510(k) clearance record for 1500 ML DISPOSABLE ENEMA CONTAINER(1110), a class I device, cleared for The Healthcare Group Laboratories, Inc. on 1980-05-14 under FDA product code FCE (Enema Kit). FDA's definition for product code FCE 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...". FDA records list 29 510(k) clearances for The Healthcare Group Laboratories, Inc., from 1980-05-02 to 1985-06-07. As of 2026-09-10, FDA records show no recalls naming K800960.