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FDA 510(k)

ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR

K-Number: K021166 · 2002-05-09

ApplicantAcmi-Circon Corporation
Decision Date2002-05-09
Product CodeFDC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR is the device name listed in this FDA 510(k) record. The listed applicant is Acmi-Circon Corporation. It received FDA 510(k) clearance on 2002-05-09 under 510(k) number K021166. The device is classified under product code FDC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR?

ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR is a medical device that received FDA 510(k) clearance on 2002-05-09. The listed applicant is Acmi-Circon Corporation. The 510(k) number is K021166.

When did ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR receive FDA 510(k) clearance?

ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR received FDA 510(k) clearance on 2002-05-09, under 510(k) number K021166.

Who is the listed applicant for ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR?

The FDA 510(k) record lists Acmi-Circon Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR?

The FDA product code for ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR is FDC.

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Related Devices (Code: FDC)

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

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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