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OES Laparo-Thoraco Videoscope (Rigid)

by Olympus America, Inc.

510(k) K955456

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK955456 Date22 Feb 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HET
Device Class
Class II
Regulation
21 CFR Part 884.1720
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The OES Laparo-Thoraco Videoscope (Rigid) is a rigid videoscope designed for laparoscopic and thoracoscopic procedures. It falls under the category of gynecologic laparoscopes and accessories, enabling visual inspection of internal thoracic and abdominal cavities through minimally invasive techniques. Its rigid construction allows for precise manipulation and stable imaging during surgical interventions.

This device is intended for use in clinical settings such as operating rooms and endoscopy suites. Supplied as a reusable instrument, it requires proper sterilization between uses to maintain safety and functionality. The scope is classified as Class II under FDA regulations and holds a 510(k) clearance (K955456) for obstetrics/gynecology applications, with no specific MRI safety labeling indicated. Available in various model-specific configurations, it must be stored according to manufacturer guidelines to preserve optical clarity and structural integrity.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the OES Laparo-Thoraco Videoscope (Rigid) used for?

    The OES Laparo-Thoraco Videoscope (Rigid) is designed for laparoscopic and thoracoscopic procedures, enabling visual inspection of internal thoracic and abdominal cavities through minimally invasive techniques. Its rigid construction allows for precise manipulation and stable imaging during surgical interventions.

  • Is this device reusable or single-use?

    The OES Laparo-Thoraco Videoscope (Rigid) is supplied as a reusable instrument that requires proper sterilization between uses to maintain safety and functionality. It must be stored according to manufacturer guidelines to preserve optical clarity and structural integrity.

  • What regulatory status does this device have?

    This device is classified as Class II under FDA regulations and holds a 510(k) clearance (K955456) for obstetrics/gynecology applications. It is intended for use in clinical settings such as operating rooms and endoscopy suites.

  • Are there different models or configurations available?

    The OES Laparo-Thoraco Videoscope (Rigid) is available in various model-specific configurations. Each model may have different specifications tailored to specific surgical needs, but all share the same basic design and intended use for laparoscopic and thoracoscopic procedures.