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Laparoscopic Spray Applicator with Spinning Luers

by Micromedics, Inc. (D/B/A Nordson Medical)

510(k) K162077

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 · Special NumberK162077 Date11 Aug 2016ClearedStatusActive

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  • Withdrawn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
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
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 Laparoscopic Spray Applicator with Spinning Luers is a medical device designed for the application of two non-homogenous liquids. It is intended for use in laparoscopic procedures to facilitate the controlled delivery of these substances.

This device is manufactured by Micromedics, Inc. and received FDA 510(k) clearance under K162077. It is classified under product code GCJ and falls under the gastroenterology and urology medical specialties.

Other devices from Micromedics, Inc. (D/B/A Nordson Medical)