AMBIT TUNNELER— 510(k) K110814

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

2011-03-24

Decision date

2011-04-08

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Salt Lake City, UT, US

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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 →