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PowerStick 40101-1608

by Neo Medical Inc.

PowerStick 40101-1608 is a Class II device made by Neo Medical Inc., cleared under FDA 510(k) K071875 on 5 Nov 2007 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI B3394010116080), active as of 23 Oct 2026.

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 23 Oct 2026

Documents

510(k) K071875

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB3394010116080 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK071875 Date5 Nov 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K071875 decided 5 Nov 2007 Active
  • FDA GUDID UDI-DI B3394010116080 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K071875
  2. Listed FDA GUDID B3394010116080

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PowerStick
Generic name
Peripheral intravenous catheterization kit, non-sensing
Model / Ref / Catalog
40101-1608
Primary DI / UDI-DI
B3394010116080
510(k) Number
FDA product code
LJS
GMDN term
Peripheral intravenous catheterization kit, non-sensing
Device class
Class II
Regulation number
880.5970
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Pressure — 300 Pound per Square Inch
Length — 8.0 Centimeter
Catheter Gauge — 4.0 French

Related devices

Category: Peripheral intravenous catheterization kit, non-sensing

Cleared under the same submission (K071875)

and 8 more cleared under K071875

Similar devices

Other devices filed under FDA product code LJS (Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days).

Other devices from Neo Medical Inc.

See all devices from Neo Medical Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)