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Iogyn System

by Iogyn, Inc. 2 variants

De Novo DEN130040

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN130040 Date28 Mar 2014DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 11 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Specification

De Novo

De Novo Number
FDA Product Code
PGT
Device Class
Class II
Regulation
21 CFR Part 884.1710
Advisory Committee
Obstetrics/Gynecology
FDA Decision
DENG De Novo granted

Other devices from Iogyn, Inc.

  • IOGYN Endoscope

    Class II

  • Iogyn System

    Class II