FOREIGN BODY PROTECTOR— 510(k) K841258

Name: FDA 510(k) clearance K841258
Creator: U.S. Food and Drug Administration
Published: 1984-07-09

Substantially Equivalent

Jayco Pharmaceuticals

FDA 510(k) clearance K841258 for FOREIGN BODY PROTECTOR, Substantially Equivalent on 1984-07-09. Applicant: Jayco Pharmaceuticals. Device class: 2.

Clearance details

Applicant: Jayco Pharmaceuticals
Product code: Code FED
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1984-03-26
Decision date: 1984-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K252572 — Prodeon Urethral Sheath System2025-10-07

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K844689 — ENDOSCOPIC MANUAL AIR INSUFFLATOR1985-01-02
K844690 — ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT1985-01-02
K844691 — ENDOSCOPIC ASPIRATION CATHETER SET1985-01-02
K842009 — ABDOMINAL PARACENTESIS TRAY1984-10-23
K842001 — LIVER BIOPSY TRAY1984-10-15

Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.