CyClean Cord— 510(k) K254239

Name: FDA 510(k) clearance K254239
Creator: U.S. Food and Drug Administration
Published: 2026-03-27

Substantially Equivalent

SS GLOBAL

FDA 510(k) clearance K254239 for CyClean Cord, Substantially Equivalent on 2026-03-27. Applicant: SS GLOBAL. Device class: Unclassified.

Summary

SS GLOBAL's CyClean Cord is filed under MVL, retraction cords. The record doesn't list sizes or model numbers.

The device class is listed as U, with no regulation number. The classification panel is listed as Unknown, and the Dental review panel handled it as a Traditional 510(k).

SS GLOBAL filed from Bucheon-Si, South Korea. The decision came 88 calendar days after receipt (December 29, 2025 to March 27, 2026).

Clearance details

Applicant: SS GLOBAL
Product code: Product code MVL
Device class: Unclassified
Advisory panel: Unknown
Date received: 2025-12-29
Decision date: 2026-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bucheon-Si, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.