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)

MICRO SURGICAL DRILL SYSTEM

K-Number: K853660 · 1985-09-24

ApplicantAcumed Instruments Corp.
Decision Date1985-09-24
Product Code
DecisionSubstantially Equivalent

Device Summary

MICRO SURGICAL DRILL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Acumed Instruments Corp.. It received FDA 510(k) clearance on 1985-09-24 under 510(k) number K853660. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO SURGICAL DRILL SYSTEM?

MICRO SURGICAL DRILL SYSTEM is a medical device that received FDA 510(k) clearance on 1985-09-24. The listed applicant is Acumed Instruments Corp.. The 510(k) number is K853660.

When did MICRO SURGICAL DRILL SYSTEM receive FDA 510(k) clearance?

MICRO SURGICAL DRILL SYSTEM received FDA 510(k) clearance on 1985-09-24, under 510(k) number K853660.

Who is the listed applicant for MICRO SURGICAL DRILL SYSTEM?

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

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 Acumed Instruments Corp. 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.

K863627MICRO SURGICAL DRILL SYSTEMK853659POWERED IRRIGATION FOR MICRO SURGICAL DRILLK853658BURS FOR MICRO SURGICAL DRILL SYSTEMK791891ACU-MED RED MISER HEMOTHORAX BLOOD COLL.K791399ACU-ALERTK791400GASTRIC LAVAGE KIT-DISPOSABLE

View all 8 devices →

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.

↑