STEPPER— 510(k) K771539

Name: FDA 510(k) clearance K771539
Creator: U.S. Food and Drug Administration
Published: 1977-10-07

Substantially Equivalent

Tridak

FDA 510(k) clearance K771539 for STEPPER, Substantially Equivalent on 1977-10-07. Applicant: Tridak. Device class: 1.

Clearance details

Applicant: Tridak
Product code: Code KYX
Device class: Class 1
Regulation: 21 CFR 880.6430
Advisory panel: General Hospital
Date received: 1977-08-11
Decision date: 1977-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K801008 — MULTI-AD FLUID DISPENSING PUMP MP-30001980-06-02

Adverse events under product code KYX

product code KYX

Death: 3
Other: 8
Total: 11

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.