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FDA 510(k)

FAS SET #4551

K-Number: K013497 · 2001-11-09

ApplicantGynetics Medical Products NV
Decision Date2001-11-09
Product CodeMQE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FAS SET #4551 is the device name listed in this FDA 510(k) record. The listed applicant is Gynetics Medical Products NV. It received FDA 510(k) clearance on 2001-11-09 under 510(k) number K013497. 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 FAS SET #4551?

FAS SET #4551 is a medical device that received FDA 510(k) clearance on 2001-11-09. The listed applicant is Gynetics Medical Products NV. The 510(k) number is K013497.

When did FAS SET #4551 receive FDA 510(k) clearance?

FAS SET #4551 received FDA 510(k) clearance on 2001-11-09, under 510(k) number K013497.

Who is the listed applicant for FAS SET #4551?

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

What is the FDA product code for FAS SET #4551?

The FDA product code for FAS SET #4551 is MQE.

Other records listing Gynetics Medical Products NV 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.

K041237ECHOSAMPLERK013501IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, BK013536EMTRAC; DELPHIN; SEMTRAC 2000 SET

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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