KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601— 510(k) K070360

Substantially Equivalent

Kirwan Surgical Products, Inc.

FDA 510(k) clearance K070360 for KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601, Substantially Equivalent on 2007-08-07. Applicant: Kirwan Surgical Products, Inc..

Clearance details

Applicant: Kirwan Surgical Products, Inc.
Product code: Code LFL
Advisory panel: Unknown
Date received: 2007-02-07
Decision date: 2007-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marshfield, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

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.