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Surgical Suction Instrument-Reusable

by Lawton Surgical Instruments

510(k) K840007

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 NumberK840007 Date6 Mar 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  • Withdrawn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
JOL
Device Class
Class II
Regulation
21 CFR Part 880.6740
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

This device is a Surgical Suction Instrument – Reusable, classified under product code JOL. It is designed for intraoperative use to aspirate fluids, debris, or smoke from surgical sites, ensuring clear visibility and maintaining a sterile environment during procedures.

The instrument is intended for reusable applications in general hospital settings. It is cleared by the FDA under a 510(k) submission (K840007) with a Traditional review pathway, classified as substantially equivalent to a predicate device. No additional regulatory markings or sterility claims are specified in the data.

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