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FDA 510(k)

ClearSafe Closed System

K-Number: K261041 · 2026-07-10

ApplicantMedSource Labs, LLC
Decision Date2026-07-10
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ClearSafe Closed System is the device name listed in this FDA 510(k) record. The listed applicant is MedSource Labs, LLC. It received FDA 510(k) clearance on 2026-07-10 under 510(k) number K261041. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearSafe Closed System?

ClearSafe Closed System is a medical device that received FDA 510(k) clearance on 2026-07-10. The listed applicant is MedSource Labs, LLC. The 510(k) number is K261041.

When did ClearSafe Closed System receive FDA 510(k) clearance?

ClearSafe Closed System received FDA 510(k) clearance on 2026-07-10, under 510(k) number K261041.

Who is the listed applicant for ClearSafe Closed System?

The FDA 510(k) record lists MedSource Labs, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearSafe Closed System?

The FDA product code for ClearSafe Closed System is FOZ.

Other records listing MedSource Labs, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterK193278MedSource CathMED IV Catheter

Related Devices (Code: FOZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260165Unimpregnated Central Venous CatheterSpectrum VascularK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, Inc.K252513Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)Poly Medicure LimitedK252398SURFLO Hybria Closed System Safety IV CatheterTerumo Medical Products (Hangzhou) Co., Ltd.

Official Source

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

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