FDA 510(k)

WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S

K-Number: K012068 · 2001-08-03

Decision Date2001-08-03

Product CodeMQE

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S 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 2001-08-03 under 510(k) number K012068. 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 SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S?

WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S is a medical device that received FDA 510(k) clearance on 2001-08-03. The listed applicant is Sims Portex , Ltd.. The 510(k) number is K012068.

When did WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S receive FDA 510(k) clearance?

WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S received FDA 510(k) clearance on 2001-08-03, under 510(k) number K012068.

Who is the listed applicant for WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S?

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 SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S?

The FDA product code for WALLACE OOCYTE RETRIEVAL SETS 16G, WALLACE OOCYTE RETRIEVAL SET 17G, MODELS MEONS 1633S, MEONS 1733S 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 K001555SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 K000628WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET-17G, MODEL MEONS1733

Related Devices (Code: MQE)

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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.