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Selfshield HN Self Sheathing Hypodermic Needle

by Beech Medical Products, Inc.

510(k) K972469

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK972469 Date27 Aug 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FMI
Device Class
Class II
Regulation
21 CFR Part 880.5570
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Selfshield HN Self Sheathing Hypodermic Needle is a spring-loaded, self-sheathing hypodermic needle designed for fluid transfer. It adapts to standard luer-fitting piston syringes and is classified as a single lumen hypodermic needle under regulation 880.5570.

Operation involves pressing the shield against the rubber injection site, rotating 40° clockwise, and pushing to penetrate; upon removal, the shield automatically advances to cover the needle tip. The device is supplied non-sterile and is intended for single use. It received FDA 510(k) clearance (K972469) on August 27, 1997, with a traditional review path and product code FMI, and is classified as a Class II device for general hospital use.

Other devices from Beech Medical Products, Inc.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Selfshield HN Self Sheathing Hypodermic Needle used for?

    It is designed for fluid transfer and adapts to standard luer-fitting piston syringes, allowing for safe penetration and automatic sheathing of the needle after use to reduce needlestick risk.

  • Is the Selfshield HN Self Sheathing Hypodermic Needle sterile or non-sterile when supplied?

    The device is supplied non-sterile, as stated in the device data, and is intended for single use only.

  • How does the self-sheathing mechanism work on the Selfshield HN needle?

    To use, press the shield against the rubber injection site, rotate 40° clockwise, and push to penetrate; upon withdrawal, the shield automatically advances via spring action to cover the needle tip.

  • What regulatory pathway and classification apply to the Selfshield HN Self Sheathing Hypodermic Needle?

    It received FDA 510(k) clearance (K972469) via a traditional review path, is classified under product code FMI and regulation 880.5570, and is a Class II device for general hospital use.