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FDA 510(k)

ARTHRO-PREP REST

K-Number: K812396 · 1981-11-20

ApplicantNorthwest Surgical Concepts, Inc.
Decision Date1981-11-20
Product CodeBWN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTHRO-PREP REST is the device name listed in this FDA 510(k) record. The listed applicant is Northwest Surgical Concepts, Inc.. It received FDA 510(k) clearance on 1981-11-20 under 510(k) number K812396. The device is classified under product code BWN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHRO-PREP REST?

ARTHRO-PREP REST is a medical device that received FDA 510(k) clearance on 1981-11-20. The listed applicant is Northwest Surgical Concepts, Inc.. The 510(k) number is K812396.

When did ARTHRO-PREP REST receive FDA 510(k) clearance?

ARTHRO-PREP REST received FDA 510(k) clearance on 1981-11-20, under 510(k) number K812396.

Who is the listed applicant for ARTHRO-PREP REST?

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

What is the FDA product code for ARTHRO-PREP REST?

The FDA product code for ARTHRO-PREP REST is BWN.

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 Northwest Surgical Concepts, 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.

K812395ARTHRO-PREP REST W/STAND

Related Devices (Code: BWN)

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.

K942699AIRFRAME SURGICAL DRAPE SUPPORTAlpha Surgical, Inc.K935441INFINITECH BREATH EZInfinitech, Inc.K925005ISI SELF-SUPPORTING ARMInstrumentation Specialties, Inc.K922288HOLDER, PEDIATRIC POSITIONYamashita and Hemsley Business TrustK910783SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604MSmith & Nephew Equipment GroupK902865BAUMER SURGICAL TABLESds Dental, 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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