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FDA 510(k)

XTRACTOR, MODEL M143

K-Number: K010220 · 2001-04-09

ApplicantInstruments Medicaux G.B., Inc.
Decision Date2001-04-09
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

XTRACTOR, MODEL M143 is the device name listed in this FDA 510(k) record. The listed applicant is Instruments Medicaux G.B., Inc.. It received FDA 510(k) clearance on 2001-04-09 under 510(k) number K010220. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XTRACTOR, MODEL M143?

XTRACTOR, MODEL M143 is a medical device that received FDA 510(k) clearance on 2001-04-09. The listed applicant is Instruments Medicaux G.B., Inc.. The 510(k) number is K010220.

When did XTRACTOR, MODEL M143 receive FDA 510(k) clearance?

XTRACTOR, MODEL M143 received FDA 510(k) clearance on 2001-04-09, under 510(k) number K010220.

Who is the listed applicant for XTRACTOR, MODEL M143?

The FDA 510(k) record lists Instruments Medicaux G.B., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XTRACTOR, MODEL M143?

The FDA product code for XTRACTOR, MODEL M143 is GCJ.

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Other records listing Instruments Medicaux G.B., Inc. 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.

K022979LAPARETTE, MODEL LAP J L S H N

Related Devices (Code: GCJ)

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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Official Source

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