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FDA 510(k)

AC POWERED THERMAL CAUTERY UNIT

K-Number: K000893 · 2000-06-14

ApplicantStarion Instruments
Decision Date2000-06-14
Product CodeHQO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AC POWERED THERMAL CAUTERY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Starion Instruments. It received FDA 510(k) clearance on 2000-06-14 under 510(k) number K000893. The device is classified under product code HQO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AC POWERED THERMAL CAUTERY UNIT?

AC POWERED THERMAL CAUTERY UNIT is a medical device that received FDA 510(k) clearance on 2000-06-14. The listed applicant is Starion Instruments. The 510(k) number is K000893.

When did AC POWERED THERMAL CAUTERY UNIT receive FDA 510(k) clearance?

AC POWERED THERMAL CAUTERY UNIT received FDA 510(k) clearance on 2000-06-14, under 510(k) number K000893.

Who is the listed applicant for AC POWERED THERMAL CAUTERY UNIT?

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

What is the FDA product code for AC POWERED THERMAL CAUTERY UNIT?

The FDA product code for AC POWERED THERMAL CAUTERY UNIT is HQO.

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Other records listing Starion Instruments 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.

K070871STARION UNIVERSAL POWER SUPPLYK062257STARION INSTRUMENTS THERMAL LITIGATING SHEARSK050308THERMAL CAUTERY PROBEK043155STARION UNIVERSAL POWER SUPPLY (UPS)K002547STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTORK001262THERMAL CAUTERY FORCEPS

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Related Devices (Code: HQO)

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.

K070871STARION UNIVERSAL POWER SUPPLYStarion InstrumentsK043155STARION UNIVERSAL POWER SUPPLY (UPS)Starion InstrumentsK002341THERMAL CAUTERY UNIT, MODEL 150Geiger Medical Technologies, Inc.K971538MENTOR GEMINI HEMOSTATIC ERASERMentor Ophthalmics, Inc.K962135D.O.R.C. MICRODIATHERMY SYSTEMDutch Ophthalmic USA, Inc.K943031BIPOLAR ELECTROSURGICAL PENCILBoston Surgical Products, 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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