Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PS3500 ARTHROSCOPIC SURGICAL SYSTEM

K-Number: K892062 · 1989-06-23

ApplicantDyonics, Inc.
Decision Date1989-06-23
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PS3500 ARTHROSCOPIC SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dyonics, Inc.. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K892062. 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 PS3500 ARTHROSCOPIC SURGICAL SYSTEM?

PS3500 ARTHROSCOPIC SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Dyonics, Inc.. The 510(k) number is K892062.

When did PS3500 ARTHROSCOPIC SURGICAL SYSTEM receive FDA 510(k) clearance?

PS3500 ARTHROSCOPIC SURGICAL SYSTEM received FDA 510(k) clearance on 1989-06-23, under 510(k) number K892062.

Who is the listed applicant for PS3500 ARTHROSCOPIC SURGICAL SYSTEM?

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

What is the FDA product code for PS3500 ARTHROSCOPIC SURGICAL SYSTEM?

The FDA product code for PS3500 ARTHROSCOPIC SURGICAL SYSTEM 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 Dyonics, 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.

K900070MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEMK896416DYONICS SHOULDER PORTAL SYSTEMK893136SURGI-PAK FOR ARTHROSCOPIC ACROMIOPLASTYK890665MODIFIED CANNULA, TROCAR AND OBTURATOR ACCESSORIESK894728DYONICS DISPOSABLE ARTHROSCOPIC SURGICAL KNIFEK884839MODIFIED SAW BLADES TO THE SAGITAL SAW

View all 19 devices →

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

View on FDA Database →

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

↑