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FDA 510(k)

PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)

K-Number: K014160 · 2002-02-08

ApplicantCook Urological, Inc.
Decision Date2002-02-08
Product CodeMQG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES) is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 2002-02-08 under 510(k) number K014160. The device is classified under product code MQG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)?

PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES) is a medical device that received FDA 510(k) clearance on 2002-02-08. The listed applicant is Cook Urological, Inc.. The 510(k) number is K014160.

When did PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES) receive FDA 510(k) clearance?

PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES) received FDA 510(k) clearance on 2002-02-08, under 510(k) number K014160.

Who is the listed applicant for PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)?

The FDA 510(k) record lists Cook Urological, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES)?

The FDA product code for PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES) is MQG.

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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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