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)

I/A HANDPIECE

K-Number: K850857 · 1985-03-29

ApplicantMedical Instrument Development Laboratories, Inc.
Decision Date1985-03-29
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

I/A HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Medical Instrument Development Laboratories, Inc.. It received FDA 510(k) clearance on 1985-03-29 under 510(k) number K850857. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I/A HANDPIECE?

I/A HANDPIECE is a medical device that received FDA 510(k) clearance on 1985-03-29. The listed applicant is Medical Instrument Development Laboratories, Inc.. The 510(k) number is K850857.

When did I/A HANDPIECE receive FDA 510(k) clearance?

I/A HANDPIECE received FDA 510(k) clearance on 1985-03-29, under 510(k) number K850857.

Who is the listed applicant for I/A HANDPIECE?

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

What is the FDA product code for I/A HANDPIECE?

The FDA product code for I/A HANDPIECE is HQE.

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 Medical Instrument Development Laboratories, 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.

K102222ULTIMATE VIT ENHAMCER (UVE)K020911MID LABS AUTONOMOUS VIT ENHANCER (AVE)K992943VIT ENHANCERK971067DIGI-INJECTORK950287UNIVIT PROBEK934600MICRODRIVE

View all 22 devices →

Related Devices (Code: HQE)

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.

K212763UniVit HE, UniVit UHSVisioncare Devices, LLCK170183Cetus system, Cetus probeA.R.C Laser GmbHK153168Bi-Blade Vitrectomy CutterMedical Instrument Development LaboratoriesK121675VERSAVITSynergetics, Inc.K120170PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, 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.

↑