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Deroyal Surgical, Umbilicup

by Deroyal

510(k) K020753

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK020753 Date13 Jun 2002ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1398-2012 FDA Not yet classified initiated 20 Jan 2012
    • Terminated Z-1396-2012 FDA Not yet classified initiated 20 Jan 2012

    Device's needle may become dislodged from the cup during shipment or during use.

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  • Withdrawn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
KSR
Device Class
Class II
Regulation
21 CFR Part 864.9100
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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