K-number	K254273
Device name	Verisafe Safety Sterile Needles (SSN)
Applicant	Promisemed Hangzhou Meditech Co., Ltd.
Product code	FMI
Device class	Class II
Decision date	Apr 16, 2026
Decision	Substantially Equivalent
Regulation	880.5570

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Verisafe Safety Sterile Needles (SSN) are hypodermic single lumen needles intended for use with syringes for general purpose fluid injections and withdrawal. The device includes a safety shield that covers the needle immediately after use to minimize the risk of accidental needlestick injuries.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Verisafe Safety Sterile Needles (SSN)

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