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FDA 510(k)

TBD

K-Number: K965245 · 1997-07-03

ApplicantUtah Medical Products, Inc.
Decision Date1997-07-03
Product CodeHGI
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TBD 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 1997-07-03 under 510(k) number K965245. 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 TBD?

TBD is a medical device that received FDA 510(k) clearance on 1997-07-03. The listed applicant is Utah Medical Products, Inc.. The 510(k) number is K965245.

When did TBD receive FDA 510(k) clearance?

TBD received FDA 510(k) clearance on 1997-07-03, under 510(k) number K965245.

Who is the listed applicant for TBD?

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 TBD?

The FDA product code for TBD is HGI.

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-XXXK970077LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044)

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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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