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FDA 510(k)

MADAYAG TYPE NEEDLE

K-Number: K813462 · 1982-03-01

ApplicantOcean Medical Products, Ltd.
Decision Date1982-03-01
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MADAYAG TYPE 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 1982-03-01 under 510(k) number K813462. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MADAYAG TYPE NEEDLE?

MADAYAG TYPE NEEDLE is a medical device that received FDA 510(k) clearance on 1982-03-01. The listed applicant is Ocean Medical Products, Ltd.. The 510(k) number is K813462.

When did MADAYAG TYPE NEEDLE receive FDA 510(k) clearance?

MADAYAG TYPE NEEDLE received FDA 510(k) clearance on 1982-03-01, under 510(k) number K813462.

Who is the listed applicant for MADAYAG TYPE 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 MADAYAG TYPE NEEDLE?

The FDA product code for MADAYAG TYPE NEEDLE is KNW.

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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 NEEDLEK823693MYELOGRAPHY NEEDLEK823692SPINAL NEEDLEK813448POTTS-COURNAND STYLE NEEDLE

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Related Devices (Code: KNW)

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.

K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLCK261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharDevicor Medical Products, Inc.

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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