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FDA 510(k)

FRONT-LINE Field Sterilizer (FL135)

K-Number: K243801 · 2025-03-07

ApplicantFort Defiance Industries, LLC
Decision Date2025-03-07
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FRONT-LINE Field Sterilizer (FL135) is a medical device manufactured by Fort Defiance Industries, LLC. It received FDA 510(k) clearance on 2025-03-07 under approval number K243801. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRONT-LINE Field Sterilizer (FL135)?

FRONT-LINE Field Sterilizer (FL135) is a medical device that received FDA 510(k) clearance on 2025-03-07. It is manufactured by Fort Defiance Industries, LLC. The 510(k) number is K243801.

When was FRONT-LINE Field Sterilizer (FL135) approved by the FDA?

FRONT-LINE Field Sterilizer (FL135) received FDA 510(k) clearance on 2025-03-07, under approval number K243801.

What company makes FRONT-LINE Field Sterilizer (FL135)?

FRONT-LINE Field Sterilizer (FL135) is manufactured by Fort Defiance Industries, LLC.

What is the FDA product code for FRONT-LINE Field Sterilizer (FL135)?

The FDA product code for FRONT-LINE Field Sterilizer (FL135) is FLE.

Related Clinical Trials

NCT05623696 Effect of Non-invasive Magnetic Stimulation of the Brain on Breathlessness in Healthy Individuals. COMPLETED NCT07357168 Electromagnetic Field Therapy Versus Aerobic Exercise on Prostatic Function in Elderly With Benign Prostatic Hyperplasia ENROLLING_BY_INVITATION NCT05534581 SINGLE SHOT CHAMPION ACTIVE_NOT_RECRUITING

Other Devices by Fort Defiance Industries, LLC

K213457Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135

Related Devices (Code: FLE)

K151597Family of Steam Sterilizers B 28 seriesCefla S.C. K163337Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic SterilizerMidmark Corporation K170228Belimed Steam Sterilizer MST-H TOP 5000Belimed AG K161848Family of Steam sterilizers B17 B22 SeriesCefla S.C. K180272Saniclave 250Revolutionary Science K172825MN-111W&H Sterilization S.R.L.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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