← Product Code [FDF](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF) · K970372 # GASTROSCOPE AND COLONOSCOPE NOZZLE REPLACEMENT KITS (K970372) _Precision Endoscopy of America, Inc. · FDF · Mar 11, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF/K970372 ## Device Facts - **Applicant:** Precision Endoscopy of America, Inc. - **Product Code:** [FDF](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF.md) - **Decision Date:** Mar 11, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Intended Use These endoscope nozzle replacement kits are intended for use in replacing the nozzle on 43 models of Olympus America, Inc. gastroscopes and colonoscopes. ## Device Story Endoscope nozzle replacement kit; includes 6 nozzles, 3 set screws, sealant, and tools (screwdriver, tweezers, magnifying glass). Used by service technicians to replace worn or damaged nozzles on Olympus gastroscopes and colonoscopes. Components (nozzle, screw, sealant) contact patient; tools are general-purpose accessories. Replacement process ensures proper nozzle alignment for continued endoscope function. ## Clinical Evidence No clinical data; bench testing/servicing experience cited. ## Technological Characteristics Kit components: nozzles, set screws, sealant. Tools: #1 screwdriver, tweezers, magnifying glass. No electronic, software, or energy-based components. ## 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 - Olympus America, Inc. endoscope nozzles and set screws ## 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} K 970372 Attachment E MAR 11 1997 # 510(k) Summary for Endoscope Nozzle Repair Kits Applicant: P. E. A. Products, Inc. 10969 McCormick Road Hunt Valley, Maryland 21031 Contact: Mr. Daniel M. Honeywell Phone: (800) 285-5959 ## Predicate Device: Olympus America, Inc. endoscope nozzles and set screws ## Device Description: These endoscope nozzle replacement kits are intended for use in replacing the nozzle on 43 models of Olympus America, Inc. gastroscopes and colonoscopes. Each kit includes 6 nozzles, three set screws, sealant, and the necessary tools (#1 screw driver, tweezers, and magnifying glass) to replace the nozzle. Each kit will include only the nozzle size(s) and set screw size(s) appropriate for use with the Olympus of America, Inc. endoscope models currently being used by the purchaser. ## Substantial Equivalence: The nozzles, set screws, and sealant are the only kit components that are incorporated into the endoscope and come in contact with the patient. The premarket notification contains information and documentation that these components are substantially equivalent to those used by the original manufacturer in that they are for the same intended use and have the same technological characteristics. The remaining kit components (i.e., tools) are general purpose articles not regulated by FDA as medical devices. They are provided both as a convenience and as an assurance that the proper tools are used to replace the nozzle. The applicant has extensive experience in the servicing and repair of endoscopes. This experience has demonstrated that nozzle replacement is easily performed and that proper nozzle alignment can readily be confirmed without the need for additional equipment. --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF/K970372](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/FDF/K970372) **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