← Product Code [HGI](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HGI) · K955756 # KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR (K955756) _KARL STORZ Endoscopy-America, Inc. · HGI · Nov 26, 1996 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HGI/K955756 ## Device Facts - **Applicant:** KARL STORZ Endoscopy-America, Inc. - **Product Code:** [HGI](/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HGI.md) - **Decision Date:** Nov 26, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.4120 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology - **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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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 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 (310) 558-1500 **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: ![img-0.jpeg](img-0.jpeg) Betty M. Johnson Manager, Regulatory Affairs 000055 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HGI/K955756](https://fda.innolitics.com/submissions/OB/subpart-e%E2%80%94obstetrical-and-gynecological-surgical-devices/HGI/K955756) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com