GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER— 510(k) K881213

Name: FDA 510(k) clearance K881213
Creator: U.S. Food and Drug Administration
Published: 1988-07-28

Substantially Equivalent

Geneva Laboratories, Inc.

FDA 510(k) clearance K881213 for GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER, Substantially Equivalent on 1988-07-28. Applicant: Geneva Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Geneva Laboratories, Inc.
Product code: Code KNX
Device class: Class 2
Regulation: 21 CFR 876.5250
Advisory panel: Gastroenterology, Urology
Date received: 1988-03-21
Decision date: 1988-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhorn, WI, US

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K881218 — GENT-L-KARE CLEANSING ENEMA SET1988-07-28
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

Adverse events under product code KNX

product code KNX

Malfunction: 1,064
Total: 1,064

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.