Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set— 510(k) K160200

Name: FDA 510(k) clearance K160200
Creator: U.S. Food and Drug Administration
Published: 2017-02-17

Substantially Equivalent

Cook Incorporated

FDA 510(k) clearance K160200 for Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set, Substantially Equivalent on 2017-02-17. Applicant: Cook Incorporated. Device class: 2.

Clearance details

Applicant: Cook Incorporated
Product code: Code BWC
Device class: Class 2
Regulation: 21 CFR 868.5090
Advisory panel: Anesthesiology
Date received: 2016-01-28
Decision date: 2017-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bloomington, IN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K160200

K-number listed on FDA's recall record

Z-1785-2026 — Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.Class II·Ongoing·Cook Incorporated·20260305

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160200.

Data sourced from openFDA. This site is unofficial and independent of the FDA.