510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K192679Substantially Equivalent

Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use

Gemtier Medical (Shanghai) Inc., Shanghai, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192679 is the FDA 510(k) clearance record for Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, a class II device, cleared for Gemtier Medical (Shanghai), Inc. on under FDA product code MEG (Syringe, Antistick). FDA records list 5 510(k) clearances for Gemtier Medical (Shanghai), Inc., from to . As of , FDA records show no recalls naming K192679.

Clearance record

Decision date
Received
(197 days to decision)
Product code
MEG Syringe, Antistick
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Gemtier Medical (Shanghai), Inc. #18 Jianding Rd., Fengjing Town, Jinshan District, Shanghai, 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