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Rmi Surgiccal Site Visualization Wand

by Research Medical, Inc.

510(k) K922083

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 NumberK922083 Date29 Jan 1993ClearedStatusActive

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  • Withdrawn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
FQH
Device Class
Class II
Regulation
21 CFR Part 880.5475
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

The RMI Surgical Site Visualization Wand is a lavage, jet device classified under medical specialty General Hospital. It is identified by the device name RMI SURGICCAL SITE VISUALIZATION WAND and product code FQH.

The device received FDA 510(k) clearance K922083 on January 29, 1993, with a decision of Substantially Equivalent (SESE). It is classified as a class 2 device under regulation number 880.5475, with applicant Research Medical, Inc. and date received May 4, 1992.

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