AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH— 510(k) K102460

Name: FDA 510(k) clearance K102460
Creator: U.S. Food and Drug Administration
Published: 2011-01-13

Substantially Equivalent

Summit Medical Products, Inc.

FDA 510(k) clearance K102460 for AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH, Substantially Equivalent on 2011-01-13. Applicant: Summit Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Summit Medical Products, Inc.
Product code: Code BSO
Device class: Class 2
Regulation: 21 CFR 868.5120
Advisory panel: Anesthesiology
Date received: 2010-08-27
Decision date: 2011-01-13
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BSO

product code BSO

Malfunction: 688
Total: 688

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.