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SOL-Guard Safety Needle 20G x 1"

by Anhui Hongyu Wuzhou Medical Manufacturer Co Ltd

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K190183

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06958697600352 UDI-DI Date8 Jan 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK190183 Date4 Oct 2019IssuedStatusActive

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  • Withdrawn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

GUDID

Trade name
SOL-Guard Safety Needle
Generic name
Hypodermic needle, single-use
Model / Ref / Catalog
20G x 1", SND482
Primary DI / UDI-DI
06958697600352
510(k) Number
FDA product code
FMI
GMDN term
Hypodermic needle, single-use
Device class
Class II
Regulation number
880.5570
GUDID distribution status
In Commercial Distribution

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Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date

Other properties (11)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No