Who is the manufacturer of A4907 LENS CLEANING SHEATH?

Olympus America, Inc. filed the 510(k) submission for A4907 LENS CLEANING SHEATH (K961860).

What is the FDA product code for A4907 LENS CLEANING SHEATH?

HET. It is classified under 21 CFR 884.1720 as a Class 2 device in the Obstetrics/Gynecology panel.

What is the regulatory pathway for A4907 LENS CLEANING SHEATH?

510(k) clearance (submission type: Traditional).

What are the predicate devices for A4907 LENS CLEANING SHEATH?

Cook Lens Cleaner; Wiest Optic Shaft; DevMed Lap wash.

Who can help prepare an FDA 510(k) submission like A4907 LENS CLEANING SHEATH?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

A4907 LENS CLEANING SHEATH

K961860 · Olympus America, Inc. · HET · Aug 29, 1996 · Obstetrics/Gynecology

Device Facts

Record ID	K961860
Device Name	A4907 LENS CLEANING SHEATH
Applicant	Olympus America, Inc.
Product Code	HET · Obstetrics/Gynecology
Decision Date	Aug 29, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 884.1720
Device Class	Class 2

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 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.

Indications for Use

Indicated for cleaning the objective lens surface of the Olympus LTF-V OES Laparo-Thoraco Videoscope during endoscopic procedures.

Regulatory Classification

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

Related Devices

K153773 — Disposal Lens Cleaning Sheath · Olympus Medical Systems Corp. · Nov 22, 2016
K152531 — InstaClear Lens Cleaner · Gyrus Acmi, Inc. · Jan 15, 2016
K080051 — VIRTUAL PORTS ENDOCLEAR SYSTEM · Virtual Ports, Ltd. · Mar 21, 2008
K120821 — LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM · Misder, LLC · May 11, 2012
K241796 — TroCare TroKit Laparoscope Lens Wiper (CP000626) · TroCare, LLC · Oct 4, 2024

Submission Summary (Full Text)

{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