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FDA 510(k)

COLONOSCOPIC INJECTION NEEDLE, C-323/C-325

K-Number: K921800 · 1993-02-08

ApplicantMill-Rose Laboratory
Decision Date1993-02-08
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COLONOSCOPIC INJECTION NEEDLE, C-323/C-325 is the device name listed in this FDA 510(k) record. The listed applicant is Mill-Rose Laboratory. It received FDA 510(k) clearance on 1993-02-08 under 510(k) number K921800. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLONOSCOPIC INJECTION NEEDLE, C-323/C-325?

COLONOSCOPIC INJECTION NEEDLE, C-323/C-325 is a medical device that received FDA 510(k) clearance on 1993-02-08. The listed applicant is Mill-Rose Laboratory. The 510(k) number is K921800.

When did COLONOSCOPIC INJECTION NEEDLE, C-323/C-325 receive FDA 510(k) clearance?

COLONOSCOPIC INJECTION NEEDLE, C-323/C-325 received FDA 510(k) clearance on 1993-02-08, under 510(k) number K921800.

Who is the listed applicant for COLONOSCOPIC INJECTION NEEDLE, C-323/C-325?

The FDA 510(k) record lists Mill-Rose Laboratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLONOSCOPIC INJECTION NEEDLE, C-323/C-325?

The FDA product code for COLONOSCOPIC INJECTION NEEDLE, C-323/C-325 is FBK.

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Other records listing Mill-Rose Laboratory 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.

K983122MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) COMBINATION CYTOLOGY/HISTOLOGY PROCEDURAL KITK983124MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDURAL KITK971275MILL-ROSE DISPOSABLE POLYPECTOMY SNAREK962736MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLEK960880MILL-ROSE BLIND MICROBIOLOGY BRUSHK954519WANG TRANSENDOSCOPIC ASPIRATION NEEDLE

View all 46 devices →

Related Devices (Code: FBK)

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.

K260262Injection NeedleMirco-Tech (Nanjing) Co., Ltd.K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.K252021Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd.K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)Olympus Medical Systems CorporationK241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt , Ltd.K240675Endoscopic Injection NeedlesPromisemed Hangzhou Meditech Co., 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.

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