PANAMEX(TM) URETERAL STENT— 510(k) K882157

Name: FDA 510(k) clearance K882157
Creator: U.S. Food and Drug Administration
Published: 1988-08-02

Substantially Equivalent

Kingston Technologies, Inc.

FDA 510(k) clearance K882157 for PANAMEX(TM) URETERAL STENT, Substantially Equivalent on 1988-08-02. Applicant: Kingston Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Kingston Technologies, Inc.
Product code: Code FAD
Device class: Class 2
Regulation: 21 CFR 876.4620
Advisory panel: Gastroenterology, Urology
Date received: 1988-05-23
Decision date: 1988-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dayton, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Kingston Technologies, Inc.

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K935232 — HYDROTORQUE GUIDE WIRE1994-07-20
K940814 — HYDRO-M(TM) WOUND GEL1994-05-12
K940738 — KTI HY-Q(TM) WOUND DRESSING1994-05-06
K925660 — KTI TRANSPARENT WOUND DRESSING1993-04-20
K921502 — HYSORB WOUND DRESSING1992-09-29

Adverse events under product code FAD

product code FAD

Death: 2
Injury: 858
Malfunction: 2,651
Other: 1
Total: 3,512

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.