KARL STORZ CONTACT MICRO-LARYNGOSCOPES

K963426 · KARL STORZ Endoscopy-America, Inc. · EOB · Nov 7, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K963426
• Device Name: KARL STORZ CONTACT MICRO-LARYNGOSCOPES
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Nov 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Indications for Use

The KSEA Contact Micro-Laryngoscopes are intended to visualize the larynx during ENT diagnostic and surgical procedures, utilizing both panoramic vision and tissue contact vision at high magnification.

Device Story

Manually operated, reusable surgical device; provides panoramic and high-magnification tissue contact visualization of larynx. Used by ENT surgeons during diagnostic and surgical procedures. Device provides direct optical visualization to assist in clinical decision-making and surgical navigation within the airway.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Constructed of surgical grade stainless steel. Manually operated, reusable optical instrument. Provides variable magnification. No energy source or software components.

Indications for Use

Indicated for visualization of the larynx during ENT diagnostic and surgical procedures in patients requiring laryngeal examination or intervention.

Regulatory Classification

Identification

A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

Submission Summary (Full Text)

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Karl Storz

Endoscopy-America, Inc.

600 Corporate Pointe

Culver City, California 90230-7600

Phone [phone]

Toll Free 800 421 0837

Fax [phone]

K963426

NOV - 7 1996

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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

[phone]

**Contact:**

Marika Anderson

Senior Regulatory Affairs Specialist

**Device Identification:**

Common Name

Micro-Laryngoscope

Trade Name

Karl Storz Contact Micro-Laryngoscopes

**Indication:** The KSEA Contact Micro-Laryngoscopes are intended to visualize the larynx during ENT diagnostic and surgical procedures, utilizing both panoramic vision and tissue contact vision at high magnification.

**Device Description:** The KSEA Contact Micro-Laryngoscope is a manually operated, reusable surgical device with an assortment of magnifying powers. The Micro-Laryngoscope is long enough to gain access to the surgical site. The body contact materials are surgical grade stainless steel.

**Substantial Equivalence:** The KSEA Contact Micro-Laryngoscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences in design and dimensions between the KSEA Contact Micro-Laryngoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.

**Signed:**

Marika Anderson

Senior Regulatory Affairs Specialist