← Product Code [BWC](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC) · K010016

# MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER (K010016)

_Cook, Inc. · BWC · Oct 9, 2001 · Anesthesiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC/K010016

## Device Facts

- **Applicant:** Cook, Inc.
- **Product Code:** [BWC](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC.md)
- **Decision Date:** Oct 9, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 868.5090
- **Device Class:** Class 2
- **Review Panel:** Anesthesiology

## Regulatory Identification

An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.

---

**Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC/K010016](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/BWC/K010016)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com