ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT— 510(k) K844690

Name: FDA 510(k) clearance K844690
Creator: U.S. Food and Drug Administration
Published: 1985-01-02

Substantially Equivalent

Jayco Pharmaceuticals

FDA 510(k) clearance K844690 for ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT, Substantially Equivalent on 1985-01-02. Applicant: Jayco Pharmaceuticals. Device class: 1.

Clearance details

Applicant: Jayco Pharmaceuticals
Product code: Code FCL
Device class: Class 1
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1984-12-03
Decision date: 1985-01-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camp Hill, PA, US

Download summary PDF View on FDA.gov ↗

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K844689 — ENDOSCOPIC MANUAL AIR INSUFFLATOR1985-01-02
K844691 — ENDOSCOPIC ASPIRATION CATHETER SET1985-01-02
K842009 — ABDOMINAL PARACENTESIS TRAY1984-10-23
K842001 — LIVER BIOPSY TRAY1984-10-15
K841258 — FOREIGN BODY PROTECTOR1984-07-09

Adverse events under product code FCL

product code FCL

Death: 5
Total: 5

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.