MEDISTIM VERIQC SYSTEM— 510(k) K102595

Substantially Equivalent

Medi-Stim Asa

FDA 510(k) clearance K102595 for MEDISTIM VERIQC SYSTEM, Substantially Equivalent on 2010-12-27. Applicant: Medi-Stim Asa. Device class: 2.

Clearance details

Applicant: Medi-Stim Asa
Product code: Code DPW
Device class: Class 2
Regulation: 21 CFR 870.2100
Advisory panel: Cardiovascular
Date received: 2010-09-09
Decision date: 2010-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fridley, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DPW

K260700 — BlueDop Vascular Expert2026-07-08
K252810 — FloPatch FP1202026-04-24
K251904 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01) +1 more2025-11-20
K251114 — FloPatch FP1202025-06-20
K243852 — Elfor-L2025-04-14

Recalls naming K102595

K-number listed on FDA's recall record

Z-0410-2026 — Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: NoClass II·Ongoing·Medistim Asa·20250926

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102595.

Data sourced from openFDA. This site is unofficial and independent of the FDA.