FDA 510(k)

ACCI-GUARD REUSABLE HOLDER

K-Number: K895075 · 1989-10-31

Decision Date1989-10-31

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ACCI-GUARD REUSABLE HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Medical Safety Products, Inc.. It received FDA 510(k) clearance on 1989-10-31 under 510(k) number K895075. 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 ACCI-GUARD REUSABLE HOLDER?

ACCI-GUARD REUSABLE HOLDER is a medical device that received FDA 510(k) clearance on 1989-10-31. The listed applicant is Medical Safety Products, Inc.. The 510(k) number is K895075.

When did ACCI-GUARD REUSABLE HOLDER receive FDA 510(k) clearance?

ACCI-GUARD REUSABLE HOLDER received FDA 510(k) clearance on 1989-10-31, under 510(k) number K895075.

Who is the listed applicant for ACCI-GUARD REUSABLE HOLDER?

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

What is the FDA product code for ACCI-GUARD REUSABLE HOLDER?

The FDA product code for ACCI-GUARD REUSABLE HOLDER 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medical Safety Products, Inc. as applicant

K942624LOK-ON NEEDLE DISPOSAL CONTAINER K913329V-ACCI-GUARD(TM) REUSABLE HOLDER K890751ACCI-GUARD(TM) I.V. CATHETER PLACEMENT UNIT K884139ACCI-GUARD(TM) REGULAR AND PEDIATRIC HOLDER K881654ACCI-GUARD MULTI-SAMPLE BLOOD COLLECTION NEEDLE

Related Devices (Code: FMI)

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHD K261719Promisemed 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

View on FDA Database →

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