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Dynatech JD7/JD7P Colposcope

by Dynatech Cryomedical Co. 510(k)

Active United States

510(k) K761205

Overview

The Dynatech JD7/JD7P Colposcope is a diagnostic device classified as a colposcope and colpomicroscope, designed for the examination of the cervix, vagina, and vulva. It provides magnified visualization of tissue to aid in the detection and assessment of abnormalities such as dysplasia, lesions, or precancerous changes. This device is commonly used in obstetrics and gynecology to support cervical cancer screening and diagnostic procedures.

The colposcope is intended for use in clinical settings by trained healthcare professionals, including gynecologists and obstetricians. It is supplied as a reusable medical instrument and requires proper sterilization between uses to ensure patient safety. The device adheres to FDA regulations under product code HEX and was granted a 510(k) clearance (K761205) in 1976, classified as substantially equivalent to existing predicate devices. Storage and handling must comply with manufacturer guidelines to maintain functionality and sterility.

AI-generated from registry data, 20 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK761205 Date17 Dec 1976ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HEX
Device Class
Class II
Regulation
21 CFR Part 884.1630
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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