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)

CERVISCOPE OPTICAL SYSTEM

K-Number: K821616 · 1982-06-16

ApplicantFotomedics, Inc.
Decision Date1982-06-16
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CERVISCOPE OPTICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fotomedics, Inc.. It received FDA 510(k) clearance on 1982-06-16 under 510(k) number K821616. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERVISCOPE OPTICAL SYSTEM?

CERVISCOPE OPTICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1982-06-16. The listed applicant is Fotomedics, Inc.. The 510(k) number is K821616.

When did CERVISCOPE OPTICAL SYSTEM receive FDA 510(k) clearance?

CERVISCOPE OPTICAL SYSTEM received FDA 510(k) clearance on 1982-06-16, under 510(k) number K821616.

Who is the listed applicant for CERVISCOPE OPTICAL SYSTEM?

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

What is the FDA product code for CERVISCOPE OPTICAL SYSTEM?

The FDA product code for CERVISCOPE OPTICAL SYSTEM is HEX.

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: HEX)

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.

K233043Smart Scope® CXPeriwinkle Technologies Pvt., Ltd.K190187Gynescope SystemIllumigyn , Ltd.K182764Biop Digital ColposcopeBiop Medical , Ltd.K181034Pocket Colposcope SystemHadleigh Health Technologies, LLCK170446LT-300 SD Digital Video ColposcopeLutech Industries, Inc.K161871EVA (Enhanced Visual Assessment) SystemMobileodt , Ltd.

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.

↑