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)

COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM

K-Number: K972630 · 1998-02-02

ApplicantCooperSurgical, Inc.
Decision Date1998-02-02
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 1998-02-02 under 510(k) number K972630. 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 COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM?

COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM is a medical device that received FDA 510(k) clearance on 1998-02-02. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K972630.

When did COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM receive FDA 510(k) clearance?

COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM received FDA 510(k) clearance on 1998-02-02, under 510(k) number K972630.

Who is the listed applicant for COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM?

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

What is the FDA product code for COOPERSURGICAL DIGITAL COLPOSCOPY SYSTEM?

The FDA product code for COOPERSURGICAL DIGITAL COLPOSCOPY 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 CooperSurgical, 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.

K261083Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)K243799Fetal PillowK250438CooperSurgical Milex® PessariesK223064ALLY II Uterine Positioning System™ (UPS)K201086Advincula Delineator Uterine ManipulatorK200038Endosee System

View all 37 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.

↑