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SonoLong SoftSecure 521189-31A

by Pajunk GmbH Medizintechnologie

SonoLong SoftSecure 521189-31A is a Class II device made by Pajunk GmbH Medizintechnologie, cleared under FDA 510(k) K113188 on 1 Mar 2012 and listed in FDA GUDID since 30 Jan 2025 (UDI-DI 04048223088241), active as of 22 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 22 Oct 2026

Documents

510(k) K113188

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04048223088241 UDI-DI Date30 Jan 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK113188 Date1 Mar 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K113188 decided 1 Mar 2012 Active
  • FDA GUDID UDI-DI 04048223088241 listed 30 Jan 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K113188
  2. Listed FDA GUDID 04048223088241

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SonoLong SoftSecure
Generic name
Peripheral anaesthesia catheter set, non-medicated
Model / Ref / Catalog
521189-31A
Primary DI / UDI-DI
04048223088241
510(k) Number
FDA product code
CAZ
GMDN term
Peripheral anaesthesia catheter set, non-medicated
Device class
Class II
Regulation number
868.5140
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Size
Length — 100.0 Millimeter
Needle Gauge — 19.0 Gauge

Related devices

Category: Peripheral anaesthesia catheter set, non-medicated

Cleared under the same submission (K113188)

and 7 more cleared under K113188

Similar devices

Other devices filed under FDA product code CAZ (Anesthesia conduction kit).

Other devices from Pajunk GmbH Medizintechnologie

See all devices from Pajunk GmbH Medizintechnologie →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)