KARL STORZ REMORGIDA FORCEPS

K962083 · KARL STORZ Endoscopy-America, Inc. · KNS · Nov 1, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962083
• Device Name: KARL STORZ REMORGIDA FORCEPS
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Nov 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Karl Storz Remorgida forceps are designed to grasp, coagulate and cut tissue during laparoscopic surgical procedures in gynecology, including but not limited to laparoscopic separation of adhesions, laparoscopically assisted vaginal hysterectomy, uretosacral nerve ablation, laparoscopic oophorectomy, laparoscopic ovarian cystectomy and laparoscopic myomectomy.

Device Story

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

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: surgical grade stainless steel and PEEK. Configuration: bipolar forceps with integrated retractable knife. Operation: manual. Reusable.

Indications for Use

Indicated for patients undergoing laparoscopic gynecological surgical procedures requiring tissue grasping, coagulation, and cutting.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

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 800 421 083
Fax [phone]
K962083
NOV - 1 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:**
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 in gynecology, including but not limited to laparoscopic separation of adhesions, laparoscopically assisted vaginal hysterectomy, uretosacral nerve ablation, laparoscopic oophorectomy, laparoscopic ovarian cystectomy and laparoscopic myomectomy.

**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:

000051