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Skin Scrub Tray

by Grand Medical Products

510(k) K963721

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 NumberK963721 Date27 Nov 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  • Withdrawn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
LRO
Device Class
Class II
Regulation
21 CFR Part 878.4370
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Skin Scrub Tray is a medical device used for skin scrubbing. It is classified as a General and Plastic Surgery device with product code LRO.

The Skin Scrub Tray is supplied by Grand Medical Products and has been cleared through the Traditional 510(k) pathway with FDA clearance number K963721. The device is a Class 2 device and has been assigned the decision code SESE, indicating substantial equivalence.

Other devices from Grand Medical Products

See all devices from Grand Medical Products →

Questions

AI-generated answers, 28 Sep 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 Skin Scrub Tray used for?

    The Skin Scrub Tray is used for skin scrubbing, specifically in general and plastic surgery applications.

  • How is the Skin Scrub Tray supplied?

    The Skin Scrub Tray is supplied by Grand Medical Products.

  • What is the regulatory status of the Skin Scrub Tray?

    The Skin Scrub Tray has been cleared through the Traditional 510(k) pathway with FDA clearance number K963721, indicating substantial equivalence.