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FDA 510(k)

UTAH ESSU

K-Number: K905263 · 1991-09-18

ApplicantUtah Medical Products, Inc.
Decision Date1991-09-18
Product CodeHGI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

UTAH ESSU 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 1991-09-18 under 510(k) number K905263. 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 UTAH ESSU?

UTAH ESSU is a medical device that received FDA 510(k) clearance on 1991-09-18. The listed applicant is Utah Medical Products, Inc.. The 510(k) number is K905263.

When did UTAH ESSU receive FDA 510(k) clearance?

UTAH ESSU received FDA 510(k) clearance on 1991-09-18, under 510(k) number K905263.

Who is the listed applicant for UTAH ESSU?

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 UTAH ESSU?

The FDA product code for UTAH ESSU is HGI.

Other records listing Utah Medical Products, Inc. as applicant

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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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