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Medline Surgical Sponge Scanner

by Medline Industries, Inc. 510(k)

Active United States

510(k) K061316

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK061316 Date2 Nov 2006ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-2321-2008 FDA Unclassified (pre-2012) initiated 13 Jun 2008 on shared 510(k) K061316

    There is the potential for the RF ID tag to separate from the retaining pouch.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
LWH
Device Class
Class I
Regulation
21 CFR Part 880.2740
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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