MEDICON INSTRUMENTS CHOLANGIOGRAPHY NEEDLES, GUIDE TUBES, INJECTION NEEDLES, VERRES INSUFFLATION NEEDLES AND HOLDERS— 510(k) K936248

Substantially Equivalent

Medicon Instruments, Inc.

FDA 510(k) clearance K936248 for MEDICON INSTRUMENTS CHOLANGIOGRAPHY NEEDLES, GUIDE TUBES, INJECTION NEEDLES, VERRES INSUFFLATION NEEDLES AND HOLDERS, Substantially Equivalent on 1994-05-16. Applicant: Medicon Instruments, Inc..

Clearance details

Applicant: Medicon Instruments, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1993-12-30
Decision date: 1994-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.