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FDA 510(k)

CONSENSUS(TM) BIPOLAR SYSTEM

K-Number: K922560 · 1992-09-11

ApplicantU.S. Medical Products, Inc.
Decision Date1992-09-11
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONSENSUS(TM) BIPOLAR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Medical Products, Inc.. It received FDA 510(k) clearance on 1992-09-11 under 510(k) number K922560. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONSENSUS(TM) BIPOLAR SYSTEM?

CONSENSUS(TM) BIPOLAR SYSTEM is a medical device that received FDA 510(k) clearance on 1992-09-11. The listed applicant is U.S. Medical Products, Inc.. The 510(k) number is K922560.

When did CONSENSUS(TM) BIPOLAR SYSTEM receive FDA 510(k) clearance?

CONSENSUS(TM) BIPOLAR SYSTEM received FDA 510(k) clearance on 1992-09-11, under 510(k) number K922560.

Who is the listed applicant for CONSENSUS(TM) BIPOLAR SYSTEM?

The FDA 510(k) record lists U.S. Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONSENSUS(TM) BIPOLAR SYSTEM?

The FDA product code for CONSENSUS(TM) BIPOLAR SYSTEM is KWY.

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Other records listing U.S. Medical Products, 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.

K962215CONSENSUS POSTERIOR STABILIZED KNEE-INTERCONDYLAR NOTCH ROUTERK954818CONSENSUS POSTERIOR STABILIZED KNEEK953443CONSENSUS PCL SUBSITUTING TIBIAL INSERTK952943CONSENSUS ALL POLY TIBIAK960302CONSENSUS ACETABULAR SHELL, ALL UHMWPEK960340CONSENSUS APEX DOME HOLE PLUG

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Related Devices (Code: KWY)

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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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