CYSTOSCOPY/IRRIGATION SET— 510(k) K896211

Name: FDA 510(k) clearance K896211
Creator: U.S. Food and Drug Administration
Published: 1990-01-18

Substantially Equivalent

Westmark, Sterile Packing Systems, Inc. (Sps)

FDA 510(k) clearance K896211 for CYSTOSCOPY/IRRIGATION SET, Substantially Equivalent on 1990-01-18. Applicant: Westmark, Sterile Packing Systems, Inc. (Sps). Device class: 2.

Clearance details

Applicant: Westmark, Sterile Packing Systems, Inc. (Sps)
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1989-10-26
Decision date: 1990-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Westmark, Sterile Packing Systems, Inc. (Sps)

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K896800 — IRRIGATION TRAY1990-05-24
K896799 — PARACERVICAL/PUDENDAL TRAYS1990-04-23
K896559 — INFANT FEEDING TUBE1990-03-13
K896794 — SPECIMEN CONTAINER1990-03-01
K896806 — CATHETER PLUG/PROTECTOR1990-02-26

Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.