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FDA 510(k)

KITAZATO OPU NEEDLE

K-Number: K112462 · 2012-11-26

ApplicantKitazato Medical Co., Ltd.
Decision Date2012-11-26
Product CodeMQE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KITAZATO OPU NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Kitazato Medical Co., Ltd.. It received FDA 510(k) clearance on 2012-11-26 under 510(k) number K112462. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KITAZATO OPU NEEDLE?

KITAZATO OPU NEEDLE is a medical device that received FDA 510(k) clearance on 2012-11-26. The listed applicant is Kitazato Medical Co., Ltd.. The 510(k) number is K112462.

When did KITAZATO OPU NEEDLE receive FDA 510(k) clearance?

KITAZATO OPU NEEDLE received FDA 510(k) clearance on 2012-11-26, under 510(k) number K112462.

Who is the listed applicant for KITAZATO OPU NEEDLE?

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

What is the FDA product code for KITAZATO OPU NEEDLE?

The FDA product code for KITAZATO OPU NEEDLE is MQE.

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.

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Other records listing Kitazato Medical Co., 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.

K131491KITAZATO IUI CATHETERK112396IUI CATHETERS

Related Devices (Code: MQE)

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.

K253121Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval NeedleGimbo Medical Technology Shenzhen Co., Ltd.K240523VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)Shenzhen Vitavitro Biotech Co., Ltd.K232163Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration NeedleZhejiang Horizon Medical Technology Co., Ltd.K190590Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)Allwin Medical Devices, Inc.K191291Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc.K182959Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, 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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