Sonoblock 001181-70
by Pajunk GmbH Medizintechnologie 2 variants
Sonoblock 001181-70 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 04048223050644), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241954 | Date11 Sep 2024 | StatusActive |
| United States | GUDID listing | Number04048223050644 | Date2 Apr 2021 | StatusListed |
Official records
- AccessGUDID record 04048223050644
- FDA 510(k) database K241954
- FDA 510(k) database K111374
Across registries
- FDA 510(k) K241954 decided 11 Sep 2024 Active
- FDA GUDID UDI-DI 04048223050644 listed 2 Apr 2021 Listed
Timeline
- Cleared FDA 510(k) K111374
- Listed FDA GUDID 04048223050644
- Cleared FDA 510(k) K241954
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Sonoblock
- Generic name
- Peripheral nerve-block sharp needle
- Model / Ref / Catalog
- 001181-70
- Primary DI / UDI-DI
- 04048223050644
- 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
Similar devices
Other devices filed under FDA product code BSP (NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)).
- PENCIL POINT SPINAL NEEDLE by HART ENTERPRISES, INC.
- UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE by Unisis Corp.
- PERICAN ULTRA by B. Braun Medical, Inc.
- 16GA X 6 BULLET POINT NEEDLE, FLEX STAINLESS STEE by R. J. Doyle, Inc.
- 16GA X 10 MIDDLE SIZE BULLET POINT NEEDLE by R. J. Doyle, Inc.
- DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE) by Csen, Ltd.
- RX EPIDURAL NEEDLE by EPIMED INTERNATIONAL, INC
- EPICAN EPIDURAL CANNULA, BEVEL ACCORD by Burron Medical Products, Inc.
- Reach Needle by Aerin Medical Inc.
- RK EPIDURAL NEEDLE by EPIMED INTERNATIONAL, INC.