Who is the manufacturer of KARL STORZ INTUBATION FIBERSCOPE?

KARL STORZ Endoscopy-America, Inc. submitted the Traditional clearance for KARL STORZ INTUBATION FIBERSCOPE (K961178).

What is the FDA product code for KARL STORZ INTUBATION FIBERSCOPE?

EOQ. It is classified under 21 CFR 874.4680 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for KARL STORZ INTUBATION FIBERSCOPE?

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

KARL STORZ INTUBATION FIBERSCOPE

K961178 · KARL STORZ Endoscopy-America, Inc. · EOQ · May 14, 1996 · Ear, Nose, Throat

Device Facts

Record ID	K961178
Device Name	KARL STORZ INTUBATION FIBERSCOPE
Applicant	KARL STORZ Endoscopy-America, Inc.
Product Code	EOQ · Ear, Nose, Throat
Decision Date	May 14, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4680
Device Class	Class 2

Intended Use

The Karl Storz intubation fiberscope is designed to provide visual access to the larynx and tracheobronchial tree during ENT endoscopic procedures.

Device Story

Fiberscope provides visual access to larynx and tracheobronchial tree; used during ENT endoscopic procedures. Device comprises focusing ocular lens, moveable eyepiece, rigid curved stainless steel shaft housing fiber optic imaging/illumination system, distal objective lens, oxygen insufflation channel, sliding cap for endotracheal catheters, and light cable connection. Operated by clinicians in ENT settings. Provides direct visualization to assist in intubation and airway management; benefits patient by enabling guided airway access.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Rigid curved stainless steel shaft; fiber optic imaging and illumination system; focusing ocular lens; oxygen insufflation channel; sliding cap for catheter accommodation. Non-electronic, mechanical/optical device.

Indications for Use

Indicated for patients requiring visual access to the larynx and tracheobronchial tree during ENT endoscopic procedures.

Regulatory Classification

Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

Related Devices

K981543 — OLYMPUS LF-TP AND LF-DP TRACHEAL INTUBATION FIBERSCOPES, ACCESSORIES AND ANCILLARY EQUIPMENT · The Olympus Optical Co. · Jun 8, 1998
K132039 — ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM · Jedmed Instrument Co. · Feb 21, 2014
K970107 — INTUBATION ENDOSCOPE AND INTRODUCER SHEATH · Urohealth Systems, Inc. · Nov 18, 1997
K083553 — NASO-LARYNGO-PHARYNGOSCOPE · Schoelly Imaging, Inc. · Jan 16, 2009
K082569 — ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE · Entellus Medical, Inc. · Sep 18, 2008

Submission Summary (Full Text)

{0} K K Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500 Toll Free 800 421 0837 Fax 310 410 5527 K961178 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS MAY 14 1996 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document are accurate and complete to the best of KSEA's knowledge. Applicant: Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230 (310) 558-1500 Contact: Betty M. Johnson Manager, Regulatory Affairs Device Identification: Common Name Fiberscope Trade Name Karl Storz intubation fiberscope Indication: The Karl Storz intubation fiberscope is designed to provide visual access to the larynx and tracheobronchial tree during ENT endoscopic procedures. Device Description: The Karl Storz intubation fiberscope consists of a focusing ocular lens, a moveable eyepiece, a rigid curved stainless steel shaft that houses the fiber optic imaging and illumination system, a distal objective lens, a channel for insufflation of oxygen, a sliding cap to accommodate endotracheal catheters of various sizes and a connection for a fiber optic light cable. Substantial Equivalence: The Karl Storz intubation fiberscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same or similar. The minor differences in dimensions between the Karl Storz intubation fiberscope and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices. Signed: Betty M. Johnson Manager, Regulatory Affairs 000044