← Product Code [HIH](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIH) · K961605 # KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE (K961605) _KARL STORZ Endoscopy-America, Inc. · HIH · Nov 13, 1996 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIH/K961605 ## Device Facts - **Applicant:** KARL STORZ Endoscopy-America, Inc. - **Product Code:** [HIH](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIH.md) - **Decision Date:** Nov 13, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.1690 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology ## Indications for Use The KSEA flexible hysteroscope is intended for hysteroscopy. ## Device Story Manually operated, reusable flexible fiberscope; 10.5 Fr. diameter; includes working channel. Used by physicians for uterine access and visualization during hysteroscopy procedures in clinical settings. Device provides direct optical visualization of uterine cavity to assist in diagnostic or surgical decision-making. Benefits include minimally invasive access to uterine anatomy. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Flexible fiber optic endoscope; 10.5 Fr. diameter; reusable; manual operation; includes working channel for instrumentation. ## Regulatory Identification A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources 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} Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600 Phone 310 558 1500 Toll Free 800 421 9437 Fax 310 410 5527 K961605 # 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 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 Hysteroscope, Flexible Fiber Optic Endoscope, Flexible Fiberscope, Flexible Hysterofiberscope Trade Name Karl Storz 10.5 Fr. Flexible Hysteroscope **Indication:** The KSEA flexible hysteroscope is intended for hysteroscopy. **Device Description:** The KSEA 10.5 Fr. flexible hysteroscope is a manually operated, reusable surgical device consisting of a flexible fiberscope with working channel. The instrument is long enough to gain access to the uterus. **Substantial Equivalence:** The KSEA 10.5 Fr. flexible hysteroscope is 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 10.5 Fr. flexible hysteroscope 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: Betty M. Johnson Manager, Regulatory Affairs 000084 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIH/K961605](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIH/K961605) **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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