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SonoBlock 001181-94

by Pajunk GmbH Medizintechnologie

SonoBlock 001181-94 is a Class II device made by Pajunk GmbH Medizintechnologie, cleared under FDA 510(k) K241954 on 11 Sep 2024 and listed in FDA GUDID since 1 Jul 2025 (UDI-DI 04048223071274), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K241954

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 Number04048223071274 UDI-DI Date1 Jul 2025ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK241954 Date11 Sep 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241954 decided 11 Sep 2024 Active
  • FDA GUDID UDI-DI 04048223071274 listed 1 Jul 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K241954
  2. Listed FDA GUDID 04048223071274

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SonoBlock
Generic name
Peripheral nerve-block sharp needle
Model / Ref / Catalog
001181-94
Primary DI / UDI-DI
04048223071274
510(k) Number
FDA product code
BSP
GMDN term
Peripheral nerve-block sharp needle
Device class
Class II
Regulation number
868.5150
GUDID distribution status
Not in Commercial Distribution
Size
Length — 70.0 Millimeter
Needle Gauge — 23.0 Gauge

Related devices

Cleared under the same submission (K241954)

and 8 more cleared under K241954

Similar devices

Other devices filed under FDA product code BSP (NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)).

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)