K963852 · KARL STORZ Endoscopy-America, Inc. · HGI · Dec 10, 1996 · Obstetrics/Gynecology
Device Facts
Record ID
K963852
Device Name
KSEA THERMOCOAGULATOR (MODEL 265100 20)
Applicant
KARL STORZ Endoscopy-America, Inc.
Product Code
HGI · Obstetrics/Gynecology
Decision Date
Dec 10, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 884.4120
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The KSEA Thermocoagulator is intended to be used for the laparoscopic treatment of endometriosis, coagulation of biopsy sites, hemostasis, coagulation of blood vessels and separation of adhesions.
Device Story
KSEA Thermocoagulator (model 265100 20) is an electrosurgical generator for laparoscopic procedures. System includes generator unit, footswitch, power cord, and probe connection cord. User-adjustable settings: coagulation time (10-70 seconds) and instrument temperature (70-130°C). Operated by physicians in clinical/OR settings. Provides thermal energy to probes for tissue coagulation and adhesion separation. Safety features include integrated audio signals and alarms. No patient-contact materials in generator unit.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Electrosurgical generator; user-adjustable timer (10-70s) and temperature (70-130°C); includes footswitch and cabling; no patient-contact materials in generator unit; audio alarm safety system.
Indications for Use
Indicated for laparoscopic treatment of endometriosis, coagulation of biopsy sites, hemostasis, coagulation of blood vessels, and separation of adhesions in patients undergoing laparoscopic 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 310 558 1500
Toll Free 800 421 0837
Fax 310 410 5527
K963852
DEC 10 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 CRF 807.92. All data included in this documents are accurate and complete to the best of KSEA’s knowledge.
**Applicant:**
Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe
Culver City, CA 90230
(310) 558-1500
**Contact:**
Betty M. Johnson
Manager, Regulatory Affairs
**Device Identification:**
Common Name
gynecologic electrocautery generator
Trade Name (optional)
KSEA Thermocoagulator (model 265100 20)
**Indication:** The KSEA Thermocoagulator is intended to be used for the laparoscopic treatment of endometriosis, coagulation of biopsy sites, hemostasis, coagulation of blood vessels and separation of adhesions.
**Device Description:** The KSEA Thermocoagulator is composed of a generator unit, a footswitch, a cord to connect the unit to a power supply, and a cord to connect the unit to the thermocoagulation probes. The Thermocoagulator contains no are no patient contact materials. Coagulation time can be set by the end user for 10-70 seconds, and the instrument temperature can be set by the end user for 70-130°C. The safety features include a number of audio signals and alarms.
**Substantial Equivalence:** The KSEA Thermocoagulator (model 265100 20) is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA Thermocoagulator and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of this device.
**Signed:**
Betty M. Johnson
Manager, Regulatory Affairs
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