← Product Code [HET](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET) · K951343 # KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES (K951343) _KARL STORZ Endoscopy-America, Inc. · HET · Apr 11, 1996 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K951343 ## 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:** Apr 11, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.1720 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology ## Indications for Use The Karl Storz Semi-Rigid Micro-Endoscopes and Accessories are designed to allow viewing of, and access to, the surgical site during endoscopic gynecological surgical procedures. ## Device Story Straight-shafted fiberoptic endoscopes; used for visualization and access during gynecological surgery. Accessories include forceps, scissors, probes, trocars, cannulae, and needles. Operated by physicians in clinical/surgical settings. Provides direct optical visualization of surgical site to assist in diagnostic or therapeutic procedures. ## Clinical Evidence No clinical data provided; substantial equivalence based on design and intended use similarity to existing devices. ## Technological Characteristics Fiberoptic endoscope; straight-shafted design. Materials are standard medical-grade biocompatible materials. Accessories include mechanical instruments (forceps, scissors, probes, trocars, cannulae, needles). ## 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} K951343 APR 11 1996 # SUMMARY OF SAFETY AND EFFECTIVENESS 000162 {1} Karl Storz Endoscopy America, Inc. 600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500 Toll Free 800 42 0837 Fax 310 410 552 K951343 # 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: fiberoptic endoscopes and accessories Trade Name (optional): Karl Storz Semi-Rigid Micro-Endoscopes and Accessories ## Indication: The Karl Storz Semi-Rigid Micro-Endoscopes and Accessories are designed to allow viewing of, and access to, the surgical site during endoscopic gynecological surgical procedures. ## Device Description: Karl Storz Semi-Rigid Micro-Endoscopes are straight-shafted, fiberoptic endoscopes. Accessories are available for use with the Micro-Endoscopes, including forceps, scissors, probes, trocars, cannulae, and needles. The body contact materials present in these devices are commonly used in medical devices for a wide range of applications, and have a long history of biocompatibility for human use. ## Substantial Equivalence: The Karl Storz Semi-Rigid Micro-Endoscopes and Accessories for endoscopic gynecological surgery are substantially equivalent to the predicate devices, since the basic features, design and intended uses are the same. The minor differences between the Karl Storz Semi-Rigid Micro-Endoscopes and Accessories for Endoscopic Gynecological Surgery 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 the devices. Signed: Betty M. Johnson Manager, Regulatory Affairs 000163 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K951343](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K951343) **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