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FDA 510(k)

SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY

K-Number: K003608 · 2001-02-20

ApplicantAesculap, Inc.
Decision Date2001-02-20
Product CodeHGI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap, Inc.. It received FDA 510(k) clearance on 2001-02-20 under 510(k) number K003608. The device is classified under product code HGI. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY?

SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY is a medical device that received FDA 510(k) clearance on 2001-02-20. The listed applicant is Aesculap, Inc.. The 510(k) number is K003608.

When did SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY receive FDA 510(k) clearance?

SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY received FDA 510(k) clearance on 2001-02-20, under 510(k) number K003608.

Who is the listed applicant for SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY?

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

What is the FDA product code for SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY?

The FDA product code for SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY is HGI.

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Related Devices (Code: HGI)

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.

K202915IRIS Thermocoagulator and Digital ColposcopeLiger Medical, LLCK152843Liger Medical HTU-110Liger Medical, LLCK121881DOMAIN SURGICAL SYSTEMDomain Surgical, Inc.K070877ENDOCERVICAL ELECTRODE # 2Modern Medical Equipment Mfg., Ltd.K061651FISCHER CONE BIOPSY EXCISOR, MODELS 900-150, 151, 152, 154, 155, 157 AND 158Apple Medical Corp.K022593THOMAS MEDICAL ELECTRODESThomas Medical, Inc.

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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