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FDA 510(k)

SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015

K-Number: K904479 · 1990-11-02

ApplicantPercutaneous Technologies
Decision Date1990-11-02
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015 is the device name listed in this FDA 510(k) record. The listed applicant is Percutaneous Technologies. It received FDA 510(k) clearance on 1990-11-02 under 510(k) number K904479. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015?

SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015 is a medical device that received FDA 510(k) clearance on 1990-11-02. The listed applicant is Percutaneous Technologies. The 510(k) number is K904479.

When did SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015 receive FDA 510(k) clearance?

SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015 received FDA 510(k) clearance on 1990-11-02, under 510(k) number K904479.

Who is the listed applicant for SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015?

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

What is the FDA product code for SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015?

The FDA product code for SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015 is HRX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Percutaneous Technologies 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.

K903213ARTHROSCOPIC SURGICAL KNIVES MODELS 1001 AND 1002

Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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