Cleared Traditional

SONO-SERIES CORNERSTONE TECHNIQUE

K111374 · PAJUNK GmbH Medizintechnologie · Anesthesiology
Aug 2011
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K111374 is an FDA 510(k) clearance for the SONO-SERIES CORNERSTONE TECHNIQUE, a Needle, Conduction, Anesthetic (w/wo Introducer) (Class II — Special Controls, product code BSP), submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on August 29, 2011, 105 days after receiving the submission on May 16, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5150.

Submission Details

510(k) Number K111374 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2011
Decision Date August 29, 2011
Days to Decision 105 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSP — Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5150

Similar Devices — BSP Needle, Conduction, Anesthetic (w/wo Introducer)

All 151
SonoMSK
K243690 · PAJUNK GmbH Medizintechnologie · Jul 2025
SonoPlex STIM; SonoPlex II
K243682 · PAJUNK GmbH Medizintechnologie · Jun 2025
SPROTTE? STANDARD (LUER/ NRFit?) Lumbar Puncture
K250774 · PAJUNK GmbH Medizintechnologie · Jun 2025
SonoTAP and SonoTAP II
K243525 · PAJUNK GmbH Medizintechnologie · Mar 2025
SPROTTE? STANDARD (LUER/ NRFit?) Anesthesiology
K241953 · PAJUNK GmbH Medizintechnologie · Nov 2024
SonoBlock; SonoBlock II
K241954 · PAJUNK GmbH Medizintechnologie · Sep 2024