KARL STORZ REMORGIDA FORCEPS

K962030 · KARL STORZ Endoscopy-America, Inc. · GEI · Jun 14, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K962030
• Device Name: KARL STORZ REMORGIDA FORCEPS
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 14, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Karl Storz Remorgida forceps are designed to grasp, coagulate and cut tissue during laparoscopic surgical procedures, including but not limited to laparoscopic separation of adhesions, laparoscopically assisted colon resection, laparoscopic appendectomy and Nissen fundoplication.

Device Story

Manually operated, reusable laparoscopic bipolar forceps; features dual forceps in bipolar configuration and retractable surgical knife; used as accessory to laparoscope; operated by surgeons in OR; enables simultaneous grasping, coagulation, and cutting of tissue; facilitates minimally invasive procedures; benefits patient via reduced trauma and surgical efficiency.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: surgical grade stainless steel and PEEK. Configuration: bipolar forceps with integrated retractable knife. Operation: manual. Form factor: elongated for laparoscopic access.

Indications for Use

Indicated for patients undergoing laparoscopic surgical procedures requiring tissue grasping, coagulation, and cutting, including adhesion separation, colon resection, appendectomy, and Nissen fundoplication.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Submission Summary (Full Text)

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K962030

Karl Storz Endoscopy

Karl Storz
Endoscopy-America, Inc.
600 Corporate Point
Chicago, IL 60601
Phone: [phone]
800 421 0837
10 310 5527

JUN 14 1996

# 510(1) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(1) 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:**
Betty M. Johnson
Manager, Regulatory Affairs

**Device Identification:**
Common Name
Laparoscopic bipolar accessories

Trade Name
Karl Storz Remorgida forceps

**Indication:** The Karl Storz Remorgida forceps are designed to grasp, coagulate and cut tissue during laparoscopic surgical procedures, including but not limited to laparoscopic separation of adhesions, laparoscopically assisted colon resection, laparoscopic appendectomy and Nissen fundoplication.

**Device Description:** The Karl Storz Remorgida forceps are a manually operated, reusable surgical device. The instrument features two pairs of forceps in a bipolar configuration and a retractable surgical knife. The device is long enough to gain access to the surgical area and is designed to be used as an accessory to a laparoscope. The body contact materials are surgical grade stainless steel and PEEK.

**Substantial Equivalence:** The Karl Storz Remorgida forceps are 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 Karl Storz Remorgida 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:
Renate A. MacLaren, Ph.D.
Regulatory Affairs Specialist

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