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Defogging Heated Endoscope Lens Protector (Dhelp); Defogging Endoscope Lens Protector (Delp)

by New Wave Surgical Corporation

510(k) K062779

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK062779 Date5 Oct 2006ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0890-2017 FDA Class II initiated 4 Oct 2016 on shared 510(k) K062779
    • Terminated Z-0889-2017 FDA Class II initiated 4 Oct 2016 on shared 510(k) K062779

    Product sterility is compromised due to breach of the sterile barrier

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

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  • Withdrawn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
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent