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)

SURGICAL & DENTAL INSTRUMENT

K-Number: K854146 · 1985-11-13

ApplicantBaort, Inc.
Decision Date1985-11-13
Product CodeGEN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGICAL & DENTAL INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Baort, Inc.. It received FDA 510(k) clearance on 1985-11-13 under 510(k) number K854146. The device is classified under product code GEN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGICAL & DENTAL INSTRUMENT?

SURGICAL & DENTAL INSTRUMENT is a medical device that received FDA 510(k) clearance on 1985-11-13. The listed applicant is Baort, Inc.. The 510(k) number is K854146.

When did SURGICAL & DENTAL INSTRUMENT receive FDA 510(k) clearance?

SURGICAL & DENTAL INSTRUMENT received FDA 510(k) clearance on 1985-11-13, under 510(k) number K854146.

Who is the listed applicant for SURGICAL & DENTAL INSTRUMENT?

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

What is the FDA product code for SURGICAL & DENTAL INSTRUMENT?

The FDA product code for SURGICAL & DENTAL INSTRUMENT is GEN.

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

Related Devices (Code: GEN)

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.

K031828NATURALASE LP ND:YAG LASERFocus Medical, LLCK953962FORCEPSBiopsys Medical, Inc.K932385SUTURE REMOVING FORCEPSRocket of London, Ltd.K904723FORCEPSMinto Research & Development, Inc.K911159PALPATION PROBENorthgate Technologies, Inc.K900952GS-1200 GRASPING/EXTRACTING FORCEP, 10MMSolos Endoscopy, 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.

↑