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FDA 510(k)

SHARPS SHUTTLE

K-Number: K972279 · 1997-08-29

ApplicantSage Products, Inc.
Decision Date1997-08-29
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SHARPS SHUTTLE is the device name listed in this FDA 510(k) record. The listed applicant is Sage Products, Inc.. It received FDA 510(k) clearance on 1997-08-29 under 510(k) number K972279. 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 SHARPS SHUTTLE?

SHARPS SHUTTLE is a medical device that received FDA 510(k) clearance on 1997-08-29. The listed applicant is Sage Products, Inc.. The 510(k) number is K972279.

When did SHARPS SHUTTLE receive FDA 510(k) clearance?

SHARPS SHUTTLE received FDA 510(k) clearance on 1997-08-29, under 510(k) number K972279.

Who is the listed applicant for SHARPS SHUTTLE?

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

What is the FDA product code for SHARPS SHUTTLE?

The FDA product code for SHARPS SHUTTLE is FMI.

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Other records listing Sage Products, 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.

K972705RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTICK980490SAGE PRODUCTS INC, SHARPS DISPOSAL CONTAINERS WITH SCREW TOP CAPSK9739112 GALLON ALTERNATE CARE SHARPS CONTAINERK970135NITRILE GLOVESK972302POCKET COUNT OR SAFETCOUNTK964168PROCEDURE SPECIFIC KITS

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

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