← Product Code [GDB](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GDB) · K961536 # FLEXSCOPE (K961536) _Matrix Medica, Inc. · GDB · Sep 18, 1996 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GDB/K961536 ## Device Facts - **Applicant:** Matrix Medica, Inc. - **Product Code:** [GDB](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GDB.md) - **Decision Date:** Sep 18, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Intended Use The FlexScope is intended to be used for visualization of tissue in general surgical applications. ## Device Story FlexScope is a flexible, deflectable fiber optic endoscope; used by physicians to visualize tissue in body cavities or through natural orifices. Device advanced to site of interest via cannula, trocar, or open procedure. Provides direct visualization to assist clinical decision-making during surgery. Benefits include minimally invasive tissue assessment. ## Clinical Evidence Bench testing only. Included dimensional inspection, bond strength testing, optical clarity, and performance under simulated conditions. All results acceptable. ## Technological Characteristics Flexible fiber optic endoscope; deflectable design. Materials are biocompatible. Available in various diameters. No software or electronic components described. ## Regulatory Identification An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. ## Special Controls *Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9. ## Predicate Devices - Microvasive, Inc. ([K850393](/device/K850393.md)) - Codman & Shurtleff ([K871978](/device/K871978.md)) ## 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} 510(k) SUMMARY K961536 # General Information SEP 18 1998 Classification: Class II Trade Name: FlexScope™ Fiber Optic Endoscope Submitter: MatRix Medical, Inc. 14055 Grand Avenue Suite D Burnsville, MN 55337 (612) 892-0822 Contact: Amjad Ahmad President # Predicate Devices Endoscopes from: - Microvasive, Inc. K850393 - Codman & Shurtleff K871978 # Device Description The FlexScope™ is a flexible deflectable endoscope intended to allow physicians to visualize tissue in body cavities and through natural body orifices. The device is designed to be advanced to the site of interest through a cannula or trocar or may be used in an open procedure. The device will be available in various diameters. The method of construction and materials used for these flexible fiber optic endoscopes are substantially equivalent to previous endoscope products. # Intended Use The FlexScope is intended to be used for visualization of tissue in general surgical applications. MatRix Medical Inc. 18 FlexScope™ 510(k) K961536 {1} # Testing All materials are biocompatible and are suitable for this application. Physical testing of the product included: dimensional inspection, bond strength testing, optical clarity, and performance under simulated conditions. All testing of the product yielded acceptable results. # Summary of Substantial Equivalence The FlexScope family of endoscopes are constructed of the same or substantially equivalent materials as the predicate products. The sizes and configurations available are also equivalent. The clinical indications for use are identical to the predicate devices. Therefore, due to the similarity of materials to other endoscopes, the test results and the identical indications for use to other endoscopes, MatRix Medical believes these products do not raise any new safety or effectiveness issues. MatRix Medical Inc. 19 FlexScope™ 510(k) K961536 --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GDB/K961536](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/GDB/K961536) **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