# K123330: Iogyn Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: Iogyn, Inc.
- Decided: Mar 19, 2013 after 144 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K954050 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991563: Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode, Vaporisation Electrode, Coagulation Electrode, C, Henke Sass Wolf of America, Inc. (1999) Summary page 1.
- K082841: Spinal Foraminoscope, Blazejewski Medi-Tech GmbH (2009) Summary page 2.

## Indications for use
The IOGYN Endoscope is intended to provide the physician with a means for endoscopic diagnostic and therapeutic surgical procedures. It is indicated for use in diagnostic examination and therapeutic surgical procedures of, but not limited to, urology and gynecology.

Source page: https://510kreport.com/device/K123330
Methodology: https://510kreport.com/methodology