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FDA 510(k)

StarFin

K-Number: K231407 · 2023-08-29

ApplicantPremium Medical Technology, LLC
Decision Date2023-08-29
Product CodeHIF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

StarFin is the device name listed in this FDA 510(k) record. The listed applicant is Premium Medical Technology, LLC. It received FDA 510(k) clearance on 2023-08-29 under 510(k) number K231407. The device is classified under product code HIF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the StarFin?

StarFin is a medical device that received FDA 510(k) clearance on 2023-08-29. The listed applicant is Premium Medical Technology, LLC. The 510(k) number is K231407.

When did StarFin receive FDA 510(k) clearance?

StarFin received FDA 510(k) clearance on 2023-08-29, under 510(k) number K231407.

Who is the listed applicant for StarFin?

The FDA 510(k) record lists Premium Medical Technology, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for StarFin?

The FDA product code for StarFin is HIF.

Related Devices (Code: HIF)

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.

K252584Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B, wAlcor C35C)Weyo Surgical Technology , Ltd.K252318Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc.K250388ENDOFLATOR +Karl Storz SE & CO. KGK242772AirSurgN Insufflator (10030/AirSurgN)SmartsurgN, Inc.K243527High Flow Insufflation Unit (UHI-4)Olympus Medical Systems CorporationK242536TauTona Pneumoperitoneum Assist Device (TPAD)Tautona Group

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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