Who is the manufacturer of RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY?

Rusch Intl. filed the 510(k) submission for RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY (K961840).

What is the FDA product code for RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY?

BTR. It is classified under 21 CFR 868.5730 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY

Q: What are the predicate devices for RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY?

Sheridan Uncuffed Tracheal Tube Magill/Murphy Type.

K961840 · Rusch Intl. · BTR · Jun 27, 1996 · Anesthesiology

Device Facts

Record ID	K961840
Device Name	RUSCH ORAL/NASAL TRACHEAL TUBE, PLAIN MAGILL/MURPHY
Applicant	Rusch Intl.
Product Code	BTR · Anesthesiology
Decision Date	Jun 27, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5730
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The device is intended for oral or nasal intubation. It is intended for airway management.

Device Story

Clear, implant-tested PVC tracheal tube; includes radiopaque stripe for visualization; graduated centimeter markings for depth determination; available in Magill or Murphy (with side eye) configurations; sizes 2.0-7.0. Used by clinicians for airway management via oral or nasal insertion. Provides patent airway for ventilation; facilitates gas exchange. Device is single-use, sterile.

Clinical Evidence

Bench testing only. Device conforms to ASTM 1242-89 standards and meets biocompatibility requirements per ISO 10993.

Technological Characteristics

Material: Implant-tested PVC; radiopaque stripe. Standards: ASTM 1242-89, ISO 10993 (biocompatibility). Form factor: Tracheal tube with centimeter markings; sizes 2.0-7.0. Configuration: Magill or Murphy (with Murphy eye).

Indications for Use

Indicated for patients requiring oral or nasal intubation for airway management.

Regulatory Classification

Identification

A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

Predicate Devices

Sheridan Uncuffed Tracheal Tube Magill/Murphy Type

Related Devices

K961837 — RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY · Rusch Intl. · Aug 16, 1996
K150603 — Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube · Teleflexmedical, Inc. · Nov 27, 2015
K993786 — RUSCH ORAL/NASAL (SAFETY CLEAR PLUS) TRACHEAL TUBE CUFFED, MAGILL/MURPHY · Rusch Intl. · Feb 2, 2000
K151381 — Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye · Covidien · Dec 11, 2015
K091591 — FLEXICARE MEDICAL ENDOTRACHEAL TUBES · Flexicare Medical, Ltd. · Jun 17, 2009

Submission Summary (Full Text)

{0} K961840 Rusch INTERNATIONAL A Subsidiary of Teleflex Incorporated (USA) Pines Park ey, NH 03452 (603) 532-7706 FAX (603) 532-8211 JUN 27 1996 # Substantial Equivalence 510(k) Summary Rüsch Oral/Nasal Tracheal Tube, Plain- Magill/Murphy To: Whom it May Concern Date: May 10, 1996 ## Submitter/Contact- Name and Address: Miss Karenann J. Brozowski Group Regulatory Affairs Director Rüsch International Tall Pines Park Jaffrey, NH 03452 Telephone: (603) 532-7706 Fax: (603) 532-8211 ## Device Details: Trade Name: Rüsch Oral/Nasal Tracheal Tube, Plain- Magill/Murphy Common Name: Tracheal Tube Classification Name: Tube, Tracheal(w/wo Connector 73BTR) Predicate Legally Marketed Device: Sheridan Uncuffed Tracheal Tube Magill/Murphy Type {1} page 2 ## Device Description: The Rusch Oral/Nasal Tracheal Tube, Plain, Magill/Murphy consists of a clear implant tested PVC tracheal tube with radiopaque stripe. The main tube is graduated with multiple centimeter markings to allow easy determination of intubated length. A black tip area is present on the tube to aid in visualization of the tube. An optional Murphy eye provides an alternative opening. The eye is the difference between the Murphy and the Magill Tube. The device is for Nasal/Oral use. ## Device Intended Use: The device is intended for oral or nasal intubation. It is intended for airway management. ## Technological Characteristics of the Device: The device is manufactured according to ASTM 1242-89. It is equivalent in design and intended use with the Sheridan product. Both of the products are PVC with the same general appearance. The Rusch Tracheal Tube comes in sizes 2.0-7.0 inclusive. ## Bench/Laboratory Testing: Based on test data, the device conforms to ASTM 1242-89. The device is biocompatible per the requirements of ISO 10993.