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Beecher 20 Ga. Probe

by Beecher Medical Diagnostic Instrumentation

510(k) K833800

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 NumberK833800 Date4 Jan 1984ClearedStatusActive

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  • Withdrawn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
HQC
Device Class
Class II
Regulation
21 CFR Part 886.4670
Advisory Committee
Ophthalmic
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 Beecher 20 Gauge Probe is a surgical instrument classified as a Unit, Phacofragmentation device, designed for ophthalmic procedures. It is intended for use in cataract surgery or related intraocular procedures, where precise tissue manipulation or fragmentation is required. The probe’s gauge size (20) and construction are tailored for controlled application within the eye’s anterior chamber or vitreous cavity.

This probe is supplied as a single-use, sterile device, intended for use in sterile surgical settings. It is regulated under FDA 510(k) clearance (K833800) and falls under the Ophthalmic medical specialty category. The device is non-magnetic and suitable for use in non-MRI environments. Storage and handling must adhere to sterile surgical instrument protocols to ensure integrity before use.

Other devices from Beecher Medical Diagnostic Instrumentation

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 Beecher 20 Gauge Probe designed for?

    The Beecher 20 Gauge Probe is specifically designed for ophthalmic procedures, particularly cataract surgery or related intraocular operations. Its 20-gauge size and construction enable precise tissue manipulation or fragmentation within the eye’s anterior chamber or vitreous cavity, ensuring controlled application during delicate surgical tasks.

  • Is the Beecher 20 Gauge Probe single-use or reusable?

    This probe is intended for single-use only. It is supplied sterile and must remain in a sterile condition throughout its intended use in surgical settings. Reuse is not recommended or approved, as it could compromise sterility and patient safety.

  • How should the Beecher 20 Gauge Probe be stored?

    The probe must be stored following strict sterile surgical instrument protocols to maintain its integrity before use. It should be kept in its original packaging, protected from contamination, moisture, and physical damage until immediately prior to use in a sterile field.

  • Can the Beecher 20 Gauge Probe be used in MRI environments?

    No, the Beecher 20 Gauge Probe is non-magnetic but is not designed for use in MRI environments. Its intended use is strictly within non-MRI surgical settings, such as standard ophthalmic operating rooms.

  • What regulatory pathway does the Beecher 20 Gauge Probe follow?

    The Beecher 20 Gauge Probe is regulated under the FDA’s 510(k) clearance pathway, with a clearance number of K833800. It is classified as a Unit, Phacofragmentation device under the Ophthalmic specialty category and is considered substantially equivalent to prior devices in its class.