510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K192464Substantially Equivalent

Injection Pen Needle

Gangan Medical Technology Jiangsu Co., Ltd., Taizhou City, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192464 is the FDA 510(k) clearance record for Injection Pen Needle, a class II device, cleared for Gangan Medical Technology Jiangsu Co., Ltd. on under FDA product code FMI (Needle, Hypodermic, Single Lumen). FDA records list one 510(k) clearance for Gangan Medical Technology Jiangsu Co., Ltd. As of , FDA records show no recalls naming K192464.

Clearance record

Decision date
Received
(351 days to decision)
Product code
FMI Needle, Hypodermic, Single Lumen
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Gangan Medical Technology Jiangsu Co., Ltd. 1st-4th Flr, Bldg. G130, Fifth Phase Of Standard Workshop, Taizhou City, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FMI

Trailing 12 months
13 clearances under product code FMI in the twelve months to October 2026, March 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FMI, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20263
April 20261
May 20260
June 20261
July 20262
August 20263
September 20261
October 20260