← Product Code [HET](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET) · K960299 # PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING LOADED PROTECTION SLEEVE (K960299) _Richard Wolf Medical Instruments Corp. · HET · Oct 28, 1996 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K960299 ## Device Facts - **Applicant:** Richard Wolf Medical Instruments Corp. - **Product Code:** [HET](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET.md) - **Decision Date:** Oct 28, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.1720 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology ## Indications for Use The pyramidal trocars with spring-return protective sleeve are designed for establishing access by piercing a vessel or chamber to facilitate insertion of the trocar sleeve (cannula) to carry out diagnostic and therapeutic measures. ## Device Story Pyramidal trocar with spring-return protective sleeve; used for establishing surgical access by piercing vessels or chambers; facilitates insertion of cannula for diagnostic/therapeutic measures; operated by surgeons in clinical/OR settings; protective sleeve shields tip post-introduction to prevent accidental injury; device provides physical access path for endoscopic instruments. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Materials: medical grade stainless steel and brass (satin chrome-plated). Design: pyramidal tip with spring-return protective sleeve mechanism for shielding. ## 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} OCI-22-1330 11:41 Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: 847.913.1113 Fax: 847.913.1488 OCT 28 1996 K960299 p142 # 510(k) Summary of Safety and Effectiveness 1.0 Classification Name: Trocar and Trocar sleeve 2.0 Common/Usual Name: Trocar and Trocar sleeve 3.0 Trade Name: Pyramidal Trocar with spring-return protective sleeve 4.0 Equivalence: These devices are equivalent to existing Richard Wolf Pre-enactment Devices and substantially equivalent to existing competitor devices on the market today. 5.0 Description: Trocars are made of medical grade stainless steel and brass (satin chrome-plated). 6.0 Intended Use: The pyramidal trocars with spring-return protective sleeve are designed for establishing access by piercing a vessel or chamber to facilitate insertion of the trocar sleeve (cannula) to carry out diagnostic and therapeutic measures. 7.0 Technological Characteristics: The trocar was specially designed to shield the tip from exposure after introduction. 8.0 Performance Data: Trocars have been tested and found to be safe when used in accordance with the intended use as outlined in the Instruction for Use Manual. 9.0 Clinical Tests: No clinical tests performed. RICHARD WOLF {1} 0C1-22-1000 1141 # Richard Wolf Medical Instruments Corporation K960299 P2012 ## 10.0 Data Conclusion Trocars from Richard Wolf are substantially equivalent to existing instruments on the market. By: Robert L. Casarsa Quality Assurance Manager Date: October 22, 1996 TOTAL P.03 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K960299](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K960299) **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. 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