510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K162947Substantially Equivalent

Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler

Chongqing Qmi Surgical Co., Ltd., Chongqing, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162947 is the FDA 510(k) clearance record for Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler and Single Use Loading Unit; Linear Cutting Stapler and Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler, a class II device, cleared for Chongqing Qmi Surgical Co., Ltd. on under FDA product code GDW (Staple, Implantable). FDA records list one 510(k) clearance for Chongqing Qmi Surgical Co., Ltd. As of , FDA records show no recalls naming K162947.

Clearance record

Decision date
Received
(133 days to decision)
Product code
GDW Staple, Implantable
Regulation
21 CFR 878.4750
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Chongqing Qmi Surgical Co., Ltd. A Zone 1st Floor, Yangliu Rd. #2 N. New Zone, Chongqing, 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