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Sonoblock 001280-71

by Pajunk GmbH Medizintechnologie

Sonoblock 001280-71 is a Class II device made by Pajunk GmbH Medizintechnologie, cleared under FDA 510(k) K241954 on 11 Sep 2024 (1 earlier submission) and listed in FDA GUDID since 2 Apr 2021 (UDI-DI 04048223051580), 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

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK241954 Date11 Sep 2024DecidedStatusActive
United StatesGUDID listing Number04048223051580 UDI-DI Date2 Apr 2021ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241954 decided 11 Sep 2024 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04048223051580 listed 2 Apr 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K111374
  2. Listed FDA GUDID 04048223051580
  3. Cleared FDA 510(k) K241954

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  • Withdrawn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
001280-71
Primary DI / UDI-DI
04048223051580
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

Related devices

Cleared under the same submission (K111374)

and 8 more cleared under K111374

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
Other properties (11, all answered No)