Ancora Nerve Block Catheter Set— 510(k) K191290

Name: FDA 510(k) clearance K191290
Creator: U.S. Food and Drug Administration
Published: 2020-02-06

Substantially Equivalent

Ancora Medical Technology

FDA 510(k) clearance K191290 for Ancora Nerve Block Catheter Set, Substantially Equivalent on 2020-02-06. Applicant: Ancora Medical Technology. Device class: 2.

Clearance details

Applicant: Ancora Medical Technology
Product code: Code BSP
Device class: Class 2
Regulation: 21 CFR 868.5150
Advisory panel: Anesthesiology
Date received: 2019-05-13
Decision date: 2020-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Menlo Park, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BSP

view all

K243690 — SonoMSK2025-07-01
K243682 — SonoPlex STIM; SonoPlex II2025-06-27
K250774 — SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture2025-06-25
K243525 — SonoTAP and SonoTAP II2025-03-24
K241953 — SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology2024-11-22

Adverse events under product code BSP

product code BSP

Death: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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