FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)— 510(k) K260710

Name: FDA 510(k) clearance K260710
Creator: U.S. Food and Drug Administration
Published: 2026-06-11

Substantially Equivalent

FloShield, Inc.

FDA 510(k) clearance K260710 for FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air), Substantially Equivalent on 2026-06-11. Applicant: FloShield, Inc.. Device class: 2.

Summary

FloShield's FloShield Air System is listed in six models: 10mm and 5mm versions, each at 0, 30, and 45 degrees. It's filed under GCJ, laparoscopes for general and plastic surgery, and the record doesn't describe the system further.

Class II, 21 CFR 876.1500. The General and Plastic Surgery review panel handled it as a Traditional 510(k), though the record lists Gastroenterology and Urology as the classification panel.

FloShield filed from Weatherford, Texas. The decision came 99 calendar days after FDA received it (March 4 to June 11, 2026).

Clearance details

Applicant: FloShield, Inc.
Product code: Product code GCJ
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2026-03-04
Decision date: 2026-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weatherford, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.