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FDA PRODUCT CODE · CLASS II

QNQLow Dead Space Piston Syringe

A low dead space syringe is a piston syringe designed to reduce medication waste. The device consists of a calibrated hollow barrel, a moveable plunger, and may include a needle. The device can be used by health care professions or for self-injection by the patient.

DEVICE CLASS
Class II
REGULATION
21 CFR 880.5860
MEDICAL SPECIALTY
General Hospital
REVIEW PANEL
HO
ImplantLife-sustainingGMP-exemptThird-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K252814CMT Health PTE., Ltd. · 510k2026-02-19
K250127Tsk Laboratory, Japan · 510k2025-07-30
K250138Prosum Medical Limited · 510k2025-04-02
K242291Sol-Millennium Medical, Inc. · 510k2024-11-20

Related on SPEQ

Medical devices industryMedical device quality (ISO 13485)FDA device clearancesFDA enforcement & recalls

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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