Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PATIENT SAFE LUER CAP

K-Number: K101708 · 2011-02-24

ApplicantRetractable Technologies, Inc.
Decision Date2011-02-24
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PATIENT SAFE LUER CAP is the device name listed in this FDA 510(k) record. The listed applicant is Retractable Technologies, Inc.. It received FDA 510(k) clearance on 2011-02-24 under 510(k) number K101708. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATIENT SAFE LUER CAP?

PATIENT SAFE LUER CAP is a medical device that received FDA 510(k) clearance on 2011-02-24. The listed applicant is Retractable Technologies, Inc.. The 510(k) number is K101708.

When did PATIENT SAFE LUER CAP receive FDA 510(k) clearance?

PATIENT SAFE LUER CAP received FDA 510(k) clearance on 2011-02-24, under 510(k) number K101708.

Who is the listed applicant for PATIENT SAFE LUER CAP?

The FDA 510(k) record lists Retractable Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PATIENT SAFE LUER CAP?

The FDA product code for PATIENT SAFE LUER CAP is FMF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Retractable Technologies, Inc. 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.

K202325EasyPoint Blood Collection PlusK122355VANISHPOINT BLOOD COLLECTION SETK112512VANISHPOINT BLOOD COLLECTION SETK081420VANISHPOINT I.V. CATHETERK072654PATIENT SAFE SYRINGEK051355VANISHPOINT I.V. CATHETER

View all 12 devices →

Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.

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.

↑