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FDA 510(k)

MYELOGRAPHY NEEDLE

K-Number: K823693 · 1983-02-07

ApplicantOcean Medical Products, Ltd.
Decision Date1983-02-07
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MYELOGRAPHY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Ocean Medical Products, Ltd.. It received FDA 510(k) clearance on 1983-02-07 under 510(k) number K823693. 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 MYELOGRAPHY NEEDLE?

MYELOGRAPHY NEEDLE is a medical device that received FDA 510(k) clearance on 1983-02-07. The listed applicant is Ocean Medical Products, Ltd.. The 510(k) number is K823693.

When did MYELOGRAPHY NEEDLE receive FDA 510(k) clearance?

MYELOGRAPHY NEEDLE received FDA 510(k) clearance on 1983-02-07, under 510(k) number K823693.

Who is the listed applicant for MYELOGRAPHY NEEDLE?

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

What is the FDA product code for MYELOGRAPHY NEEDLE?

The FDA product code for MYELOGRAPHY NEEDLE is FMI.

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Other records listing Ocean Medical Products, Ltd. 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.

K882013SOFT TISSUE BIOPSY DEVICEK870896NOTCH-NEEDLE, WESCOTT STYLEK843719SINGLE WALL INTRODUCER NEEDLEK823692SPINAL NEEDLEK813462MADAYAG TYPE NEEDLEK813448POTTS-COURNAND STYLE NEEDLE

View all 9 devices →

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

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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