KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR

K955756 · KARL STORZ Endoscopy-America, Inc. · HGI · Nov 26, 1996 · Obstetrics/Gynecology

Device Facts

• Record ID: K955756
• Device Name: KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: HGI · Obstetrics/Gynecology
• Decision Date: Nov 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.4120
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The KSEA thermocoagulation accessories are designed to thermally coagulate tissue during laparoscopic surgical procedures in gynecology.

Device Story

Manually operated, reusable laparoscopic surgical accessories; includes point coagulator, crocodile forceps, and myoma enucleator. Used as adjuncts to laparoscopes for thermal tissue coagulation in gynecological surgery. Operated by surgeons in clinical/OR settings. Devices provide mechanical access and thermal energy delivery to target tissue; facilitates hemostasis or tissue destruction. No automated processing or software components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: surgical grade stainless steel. Form factor: long-shafted instruments for laparoscopic access. Energy: thermal coagulation. Reusable. No software or electronic components.

Indications for Use

Indicated for thermal tissue coagulation during laparoscopic gynecological surgical procedures.

Regulatory Classification

Identification

A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.

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]
K955756

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

NOV 26 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
[phone]

**Contact:**
Betty M. Johnson
Manager, Regulatory Affairs

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

Trade Name
Karl Storz Thermocoagulator accessories

**Indication:** The KSEA thermocoagulation accessories are designed to thermally coagulate tissue during laparoscopic surgical procedures in gynecology.

**Device Description:** The KSEA thermocoagulator accessories are manually operated, reusable surgical devices consisting of a point coagulator, crocodile forceps and a myoma enucleator. The instruments are long enough to gain access to the surgical area and are designed to be used as accessories to laparoscopes. The body contact materials are surgical grade stainless steel.

**Substantial Equivalence:** The KSEA thermocoagulator accessories 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 KSEA thermocoagulator accessories 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:
Betty M. Johnson
Manager, Regulatory Affairs

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