510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253797Substantially Equivalent

One-Stop

Mediclus Co., Ltd, Cheongju-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253797 is the FDA 510(k) clearance record for One-Stop, cleared for Mediclus Co., Ltd. on under FDA product code MVL (Cord, Retraction). FDA records list 15 510(k) clearances for Mediclus Co., Ltd., from to . As of , FDA records show no recalls naming K253797.

Clearance record

Decision date
Received
(91 days to decision)
Product code
MVL Cord, Retraction
Device class
Unclassified
Review panel
Unknown
Applicant
Mediclus Co., Ltd. # 1210, 134, Gongdan-Ro, Heungdeok-Gu, Cheongju-Si, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MVL

Trailing 12 months
2 clearances under product code MVL in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MVL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260