ULTRA-GEL - #4083— 510(k) K864189

Name: FDA 510(k) clearance K864189
Creator: U.S. Food and Drug Administration
Published: 1986-12-04

Substantially Equivalent

John F. Greer Co., Inc.

FDA 510(k) clearance K864189 for ULTRA-GEL - #4083, Substantially Equivalent on 1986-12-04. Applicant: John F. Greer Co., Inc.. Device class: 1.

Clearance details

Applicant: John F. Greer Co., Inc.
Product code: Code EXB
Device class: Class 1
Regulation: 21 CFR 876.5900
Advisory panel: Gastroenterology, Urology
Date received: 1986-10-27
Decision date: 1986-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakland, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EXB

view all

K252140 — Heylo System2025-10-06
K181643 — SmartBag (SmartPouch)2018-11-16
K140938 — OSTOM-I ALERT2014-10-10
K922730 — LAKE OSTOMY CARE SET1993-12-30
K882878 — ODOR-END EMERGENCY CLEAN UP POWDER1988-12-08

More clearances from John F. Greer Co., Inc.

view all

K870577 — E-Z LOOP1987-04-17
K870531 — EZ TAC FILTER1987-04-10
K864190 — E-Z HOLD - #40601987-01-14
K864188 — E-Z HOLD WITH ADHESIVE BASE.-#40651986-12-04

Adverse events under product code EXB

product code EXB

Injury: 145
Total: 145

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.