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)

COLPOSCOPE SYSTEM

K-Number: K770697 · 1977-05-20

ApplicantRichard Wolf Medical Instruments Corp.
Decision Date1977-05-20
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COLPOSCOPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 1977-05-20 under 510(k) number K770697. 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 COLPOSCOPE SYSTEM?

COLPOSCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 1977-05-20. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K770697.

When did COLPOSCOPE SYSTEM receive FDA 510(k) clearance?

COLPOSCOPE SYSTEM received FDA 510(k) clearance on 1977-05-20, under 510(k) number K770697.

Who is the listed applicant for COLPOSCOPE SYSTEM?

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

What is the FDA product code for COLPOSCOPE SYSTEM?

The FDA product code for COLPOSCOPE 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

Other records listing Richard Wolf Medical 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.

K151282core nova Complete Operating Room EndoscopyK130423THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525K121724ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2K120898KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CAK090776MEGAPULSE LASER SYSTEM AND FIBERSK080617POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES

View all 142 devices →

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.

↑