510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925526Substantially Equivalent

Manipler Disposable Skin Stapler

Matsutani Seisakusho Co., Ltd., Mahwah NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925526 is the FDA 510(k) clearance record for MANIPLER DISPOSABLE SKIN STAPLER, a class I device, cleared for Matsutani Seisakusho Co. , Ltd. on under FDA product code GDT (Staple, Removable (Skin)). FDA records list one 510(k) clearance for Matsutani Seisakusho Co. , Ltd. As of , FDA records show no recalls naming K925526.

Clearance record

Decision date
Received
(234 days to decision)
Product code
GDT Staple, Removable (Skin)
Regulation
21 CFR 878.4760
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Matsutani Seisakusho Co. , Ltd. C/O The Lahr Consulting Group, Mahwah NJ
510(k) summary
Statement
Third party review
No

Clearances, product code GDT

Trailing 12 months

FDA records hold no clearances under product code GDT in the trailing twelve months.

FDA records show no clearances under product code GDT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GDT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260