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FDA 510(k)

RMS SUBCUTANEOUS NEEDLE SET

K-Number: K102512 · 2011-05-20

ApplicantRepro-Med Systems, Inc.
Decision Date2011-05-20
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RMS SUBCUTANEOUS NEEDLE SET is the device name listed in this FDA 510(k) record. The listed applicant is Repro-Med Systems, Inc.. It received FDA 510(k) clearance on 2011-05-20 under 510(k) number K102512. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RMS SUBCUTANEOUS NEEDLE SET?

RMS SUBCUTANEOUS NEEDLE SET is a medical device that received FDA 510(k) clearance on 2011-05-20. The listed applicant is Repro-Med Systems, Inc.. The 510(k) number is K102512.

When did RMS SUBCUTANEOUS NEEDLE SET receive FDA 510(k) clearance?

RMS SUBCUTANEOUS NEEDLE SET received FDA 510(k) clearance on 2011-05-20, under 510(k) number K102512.

Who is the listed applicant for RMS SUBCUTANEOUS NEEDLE SET?

The FDA 510(k) record lists Repro-Med Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RMS SUBCUTANEOUS NEEDLE SET?

The FDA product code for RMS SUBCUTANEOUS NEEDLE SET is FPA.

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 Repro-Med Systems, 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.

K981506RESTORE VACUUM ERECTION DEVICE, CONFIDE VACUUM ERECTION DEVICE, PEP (PENILE ERECTION PROGRAM), RELY VACUUM ERECTION DEV)K933652FREEDOM 60 SYRINGE INFUSION PUMP SYSTEM WITH SYRINGE SET & TUBINGK894299REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEMK892529REPRO-MED NEONATE ASPIRATION SYSTEMK844401REPRO-MED SYSTEMS INFUSION DEVICE

Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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