510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K130738Substantially Equivalent

Endoscopic Linear Cutting Staplers with Single Use Loading Units

Nanjing Maidixin Medical Device Co., Ltd., Shanghai, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130738 is the FDA 510(k) clearance record for ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS, a class II device, cleared for Nanjing Maidixin Medical Device Co., Ltd. on under FDA product code GDW (Staple, Implantable). FDA records list one 510(k) clearance for Nanjing Maidixin Medical Device Co., Ltd. As of , FDA records show no recalls naming K130738.

Clearance record

Decision date
Received
(270 days to decision)
Product code
GDW Staple, Implantable
Regulation
21 CFR 878.4750
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Nanjing Maidixin Medical Device Co., Ltd. P.O. Box 120-119, Shanghai, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GDW

Trailing 12 months
4 clearances under product code GDW in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GDW, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260