GENT-L-KARE CLEANSING ENEMA SET— 510(k) K881218

Clearance details

Applicant

Geneva Laboratories, Inc.

Product code

Code FCE

Device class

Class 1

Regulation

21 CFR 876.5210

Advisory panel

Gastroenterology, Urology

Date received

1988-03-22

Decision date

1988-07-28

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Elkhorn, WI, US

• K974042 — AMSURE CLEANSING ENEMA SET1997-12-19
• K931896 — PRO-FLO SYSTEM1993-08-26
• K922398 — 4 SURE TM ENEMA BAG SET1993-06-17
• K913620 — ENEMA KIT1991-11-01
• K904534 — ENEMA BULB1990-12-21

• K881217 — GENT-L-KARE STERILE URINARY LEG BAG1988-07-29
• K881213 — GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER1988-07-28
• K881216 — GENT-L-KARE VAGINAL IRRIGATION SET1988-06-07
• K861308 — ACCUPAC CUSTOM PACK KERLIX SQUARES1986-05-02
• K861219 — ACCUPAC CUSTOM SKIN SCRUB KIT1986-04-15

Other

2

Total

2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →