510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231734Substantially Equivalent

STERiJECT Low Dead Space, STERiJECT The Invisible Needle

TSK Laboratory International Japan KK, Tochigi-Shi, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231734 is the FDA 510(k) clearance record for STERiJECT Low Dead Space, STERiJECT The Invisible Needle, a class II device, cleared for Tsk Laboratory International Japan KK on under FDA product code QNS (Low Dead Space Needle, Single Lumen, Hypodermic). FDA's definition for product code QNS reads: "A low dead space single lumen hypodermic needle is a device designed to reduce medication waste. The device consists of a metal tube that is sharpened at one end and at the other end joined to connector designed to mate with a piston...". FDA records list 2 510(k) clearances for Tsk Laboratory International Japan KK, from to . As of , FDA records show no recalls naming K231734.

Clearance record

Decision date
Received
(268 days to decision)
Product code
QNS Low Dead Space Needle, Single Lumen, Hypodermic
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Tsk Laboratory International Japan KK 2-1-5 Hirayanagi-Cho, Tochigi-Shi, JP
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QNS

Trailing 12 months

FDA records hold no clearances under product code QNS in the trailing twelve months.

FDA records show no clearances under product code QNS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QNS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260