K260710
- 510(k) number
- K260710
- Device name
- 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)
- Applicant
- FloShield, Inc. TX · US
- Product code
- GCJ — Laparoscope, General & Plastic Surgery
- Decision date
- 2026-06-11
- Date received
- 2026-03-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K260710.pdf
Official FDA record: K260710
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.