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FDA 510(k)

FINESSE IEC/601

K-Number: K941251 · 1994-12-12

ApplicantUtah Medical Products, Inc.
Decision Date1994-12-12
Product CodeHGI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FINESSE IEC/601 is the device name listed in this FDA 510(k) record. The listed applicant is Utah Medical Products, Inc.. It received FDA 510(k) clearance on 1994-12-12 under 510(k) number K941251. 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 FINESSE IEC/601?

FINESSE IEC/601 is a medical device that received FDA 510(k) clearance on 1994-12-12. The listed applicant is Utah Medical Products, Inc.. The 510(k) number is K941251.

When did FINESSE IEC/601 receive FDA 510(k) clearance?

FINESSE IEC/601 received FDA 510(k) clearance on 1994-12-12, under 510(k) number K941251.

Who is the listed applicant for FINESSE IEC/601?

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

What is the FDA product code for FINESSE IEC/601?

The FDA product code for FINESSE IEC/601 is HGI.

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Other records listing Utah 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.

K123310FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)K101535BT-CATHK063611SALINE/ CONTRAST MEDIA INFUSION CATHETERK001874PERIPHERALLY INSERTED CENTRAL CATHETERK000974FOWLER ENDOCURETTE, MODEL CUR-XXXK965245TBD

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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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