SELF RETAINING SOFT TISSUE RETRACTOR— 510(k) K101609

Name: FDA 510(k) clearance K101609
Creator: U.S. Food and Drug Administration
Published: 2010-12-09

Substantially Equivalent

Koros USA, Inc.

FDA 510(k) clearance K101609 for SELF RETAINING SOFT TISSUE RETRACTOR, Substantially Equivalent on 2010-12-09. Applicant: Koros USA, Inc.. Device class: 1.

Clearance details

Applicant: Koros USA, Inc.
Product code: Code LXH
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 2010-06-08
Decision date: 2010-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Moorepark, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LXH

product code LXH

Death: 11
Injury: 2,218
Malfunction: 31,318
Total: 33,547

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.