510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161905Substantially Equivalent

Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge

Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd, Changzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161905 is the FDA 510(k) clearance record for Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge, a class II device, cleared for Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd on under FDA product code GDW (Staple, Implantable). FDA records list 3 510(k) clearances for Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd, from to . As of , FDA records show no recalls naming K161905.

Clearance record

Decision date
Received
(129 days to decision)
Product code
GDW Staple, Implantable
Regulation
21 CFR 878.4750
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd #51, Shuishan Rd., Zhonglou Economic Development Zone, Changzhou, 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