Cleared Traditional

One-Stop

K253797 · Mediclus Co., Ltd. · Dental

Feb 2026

Decision

91d

Days

—

Risk

About This 510(k) Submission

K253797 is an FDA 510(k) clearance for the One-Stop, a Cord, Retraction, submitted by Mediclus Co., Ltd. (Cheongju-Si, KR). The FDA issued a Cleared decision on February 27, 2026, 91 days after receiving the submission on November 28, 2025. This device falls under the Dental review panel.

Submission Details

510(k) Number	K253797 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 28, 2025
Decision Date	February 27, 2026
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF