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FDA 510(k)

PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80

K-Number: K945274 · 1994-12-14

ApplicantPro-Tec Containers, Inc.
Decision Date1994-12-14
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80 is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Tec Containers, Inc.. It received FDA 510(k) clearance on 1994-12-14 under 510(k) number K945274. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80?

PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80 is a medical device that received FDA 510(k) clearance on 1994-12-14. The listed applicant is Pro-Tec Containers, Inc.. The 510(k) number is K945274.

When did PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80 receive FDA 510(k) clearance?

PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80 received FDA 510(k) clearance on 1994-12-14, under 510(k) number K945274.

Who is the listed applicant for PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80?

The FDA 510(k) record lists Pro-Tec Containers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80?

The FDA product code for PRO-TEC DISPOSABLE SHARPS CONTAINERS IR180 & IR80 is FMI.

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 Pro-Tec Containers, 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.

K945273PRO-TECH DISPOSABLE SHARPS CONTAINERS VNC2K945275PRO-TEC DISPOSBLE SHARPS CONTAINERS Q1K945276PRO-TEC DISPOSABLE SHARPS CONTAINERS 5GK942179PRO-TEC DISPOSABLE SHARPS CONTAINERSK892665PRO-JECT(TM) SAFETY NEEDLE HOLDER

Related Devices (Code: FMI)

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.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Official Source

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