ULTRA-GEL - #4083— 510(k) K864189

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..

Clearance details

Applicant: John F. Greer Co., Inc.
Product code: Code EXB
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 ↗

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.