← Product Code [HET](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET) · K961860 # A4907 LENS CLEANING SHEATH (K961860) _Olympus America, Inc. · HET · Aug 29, 1996 · Obstetrics/Gynecology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K961860 ## Device Facts - **Applicant:** Olympus America, Inc. - **Product Code:** [HET](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET.md) - **Decision Date:** Aug 29, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 884.1720 - **Device Class:** Class 2 - **Review Panel:** Obstetrics/Gynecology ## Indications for Use The A4907 Lens Cleaning Sheath has been specifically designed to be used with the Olympus A4908 Valve and LTF-V OES V Laparo-Thoraco Videoscope to clean of the objective lens surface. ## Device Story Lens cleaning sheath; attaches to Olympus LTF-V OES Laparo-Thoraco Videoscope; provides irrigation and suction capabilities; enables cleaning of objective lens surface during endoscopic procedures; used by clinicians in surgical/endoscopic settings; maintains clear visualization; improves procedural efficiency. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Accessory for endoscope; provides irrigation and suction channels for lens cleaning; compatible with Olympus A4908 Valve and LTF-V OES Laparo-Thoraco Videoscope. ## 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. ## Predicate Devices - Cook Lens Cleaner - Wiest Optic Shaft - DevMed Lap wash ## 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} K961860 AUG 29 1996 510 (k) SUMMARY # Olympus A4907 Lens Cleaning Sheath | Device Name: | Olympus A4907 Lens Cleaning Sheath | | --- | --- | | Common/Usual Name: | Lens Cleaning Tube | | Classification Name: | Endoscope and Accessories 21 CFR 876 1500, Class II | | Predicate Devices: | Cook Lens Cleaner (Unknown) Wiest Optic Shaft (Unknown) DevMed Lap wash (Unknown) | | Submitted By: (Contact Person) | Subhash Patel Olympus America Inc. Endoscope Division Two Corporate Center Drive Melville, New York 11747-3157 (516) 844-5481 | | Summary Preparation Date: | May 8, 1996 | ## Statement of Intended Use: The A4907 Lens Cleaning Sheath has been specifically designed to be used with the Olympus A4908 Valve and LTF-V OES V Laparo-Thoraco Videoscope to clean of the objective lens surface. ## Device Description The A4907 Lens Cleaning Sheath has been specifically designed for use with the Olympus A4908 Valve and LTF-V OES Laparo-Thoraco Videoscope. It will be included in the standard set of LTF-V Laparo-Thoraco Videoscope and will also be marketed separately. When connected to the main body of LTF-V videoscope, it offers lens cleaning, irrigation, and suction capabilities to the user during endoscopic procedures. It is substantially equivalent in design, intended use, and method of operation to the “Lens Cleaner” manufactured by Cook, “Optic Shaft” manufactured by Wiest, and “Lap Wash System” manufactured by DevMed Group Inc. ## General Safety When compared with the predicate devices, Olympus A4907 Lens Cleaning Sheath does not incorporate any significant change in intended use, method of operation, material, or design that could affect the safety or effectiveness of the subject device. 41 --- **Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K961860](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HET/K961860) **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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