FDA 510(k)

WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733

K-Number: K000628 · 2000-03-13

Decision Date2000-03-13

Product CodeMQE

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733 is the device name listed in this FDA 510(k) record. The listed applicant is Sims Portex , Ltd.. It received FDA 510(k) clearance on 2000-03-13 under 510(k) number K000628. 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 WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733?

WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733 is a medical device that received FDA 510(k) clearance on 2000-03-13. The listed applicant is Sims Portex , Ltd.. The 510(k) number is K000628.

When did WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733 receive FDA 510(k) clearance?

WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733 received FDA 510(k) clearance on 2000-03-13, under 510(k) number K000628.

Who is the listed applicant for WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733?

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

What is the FDA product code for WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733?

The FDA product code for WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733 is MQE.

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Other records listing Sims Portex , Ltd. as applicant

K012277PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE K012068WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S K001555SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26

Related Devices (Code: MQE)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.