KSEA BIPOLAR GOAGULATING FORCEPS

K962396 · KARL STORZ Endoscopy-America, Inc. · EOB · Aug 27, 1996 · Ear, Nose, Throat

Device Facts

• Record ID: K962396
• Device Name: KSEA BIPOLAR GOAGULATING FORCEPS
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Aug 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KSEA Bipolar Coagulating Forceps for endoscopic and non-endoscopic ENT surgery are designed to be used with high frequency electrical current to coagulate tissue during endoscopic and non-endoscopic ENT surgical procedures.

Device Story

Manual reusable surgical forceps; used as accessories to endoscopes in ENT surgery. Device delivers high-frequency electrical current to coagulate tissue. Operated by surgeons in clinical/OR settings. Provides mechanical grasping and electrical coagulation functionality. Benefits include precise tissue hemostasis during ENT procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual reusable surgical forceps; surgical grade stainless steel construction; insulated with standard materials; bipolar electrical configuration; designed for use with high-frequency electrosurgical generators.

Indications for Use

Indicated for patients undergoing endoscopic or non-endoscopic ENT surgical procedures requiring tissue coagulation via high-frequency electrical current.

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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000048

# 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 is accurate and complete to the best of KSEA’s knowledge.

## Applicant:

Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
[phone]

K962396

## Contact:

Kevin Kennan
Regulatory Affairs Specialist

AUG 27 1996

## Device Identification:

**Common Name:**
Bipolar Forceps

**Trade Name:** (optional)
KSEA Bipolar Coagulating Forceps

## Indication:

The KSEA Bipolar Coagulating Forceps for endoscopic and non-endoscopic ENT surgery are designed to be used with high frequency electrical current to coagulate tissue during endoscopic and non-endoscopic ENT surgical procedures.

## Device Description:

The KSEA Bipolar Coagulating Forceps are manual reusable surgical devices. The KSEA Bipolar Coagulating Forceps are long enough to gain access to the surgical area and are designed to be used as accessories to endoscopes. The body contact material is surgical grade stainless steel. The Bipolar Coagulating Forceps are insulated with commonly used materials.

## Substantial Equivalence:

The KSEA Bipolar Coagulating Forceps for endoscopic and non endoscopic ENT surgical procedures are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA Bipolar Coagulating Forceps 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:
Kevin Kennan
Regulatory Affairs Specialist