← Product Code [HET](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET) · K964379 # KSEA PUNCTURE CANNULA (K964379) _KARL STORZ Endoscopy-America, Inc. · HET · Jan 29, 1997 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K964379 ## Device Facts - **Applicant:** KARL STORZ Endoscopy-America, Inc. - **Product Code:** [HET](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET.md) - **Decision Date:** Jan 29, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.1720 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology - **Attributes:** Therapeutic ## Indications for Use The KSEA Puncture Cannula are intended for use by qualified surgeons or physicians to puncture and drain a cyst or other structure within the surgical site. ## Device Story Manual reusable surgical cannula; component of KSEA Irrigation and Suction System; used with KSEA Irrigation and Suction System Handpiece. Device punctures and drains cysts or structures within surgical site. Operated by surgeons or physicians in surgical settings. Stainless steel construction. Provides mechanical access for fluid evacuation. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Manual reusable surgical cannula; surgical grade stainless steel; non-sterile; intended for use with KSEA Irrigation and Suction System Handpiece. ## Regulatory Identification A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts. ## 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} K964379 JAN 29 1997 K964379 # 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 is accurate and complete to the best of KSEA’s knowledge. ## Applicant: Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Drive Culver City, CA 90230 (310) 558-1500 ## Contact: Kevin Kennan Regulatory Affairs Specialist ## Device Identification: Common Name: Cannula Trade Name: (optional) KSEA Puncture Cannula ## Indication: The KSEA Puncture Cannula are intended for use by qualified surgeons or physicians to puncture and drain a cyst or other structure within the surgical site. ## Device Description: The KSEA Puncture Cannula are manual reusable surgical devices provided to the end-user in a non-sterile condition. The KSEA Puncture Cannula are part of the KSEA “Irrigation and Suction System” and are intended to be used with KSEA Irrigation and Suction System Handpiece. The body contact materials are surgical grade stainless steel. ## Substantial Equivalence: The KSEA Puncture Cannula for the puncture and evacuation of cysts are substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA Puncture Cannula 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) Kevin Kennan Regulatory Affairs Specialist 000065 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K964379](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K964379) **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