510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K143497Substantially Equivalent

Safety Auto-Disable Syrine with Needle (Auto-Lock)

Guangdong Intmed Medical Appliance Co., Ltd., Foshan, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K143497 is the FDA 510(k) clearance record for Safety Auto-Disable Syrine with Needle (Auto-Lock), a class II device, cleared for Guangdong Intmed Medical Appliance Co., Ltd. on under FDA product code MEG (Syringe, Antistick). FDA records list one 510(k) clearance for Guangdong Intmed Medical Appliance Co., Ltd. As of , FDA records show no recalls naming K143497.

Clearance record

Decision date
Received
(330 days to decision)
Product code
MEG Syringe, Antistick
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Guangdong Intmed Medical Appliance Co., Ltd. 1# S. Rd. Europe Industry Park, Shunde District, Foshan, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MEG

Trailing 12 months
2 clearances under product code MEG 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 MEG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260