# Medgyn Products, Inc.

- Location (FDA's records): Downers Grove, IL
- FDA decisions: 5 (1988–2015): 5 510(k) clearances
- Product codes: HEX (2), HDY (1), MQF (1), HGF (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 7 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Select Medical Systems, Inc.: 2 (https://510kreport.com/company/select-medical-systems)
- Goldway Us, Inc.: 1 (https://510kreport.com/company/goldway-us)

## Firms that cite its devices most
- Gynius AB: 2 (https://510kreport.com/company/gynius)
- Biop Medical, Ltd.: 1 (https://510kreport.com/company/biop-medical)
- CooperSurgical, Inc.: 1 (https://510kreport.com/company/coopersurgical)
- Illumigyn, Ltd.: 1 (https://510kreport.com/company/illumigyn)
- Medicem Technology S.R.O: 1 (https://510kreport.com/company/medicem-technology)
- Mobileodt, Ltd.: 1 (https://510kreport.com/company/mobileodt)

## Its most-cited devices
- K122973: AL-106, AL-106SA and AL-106B Medgyn Digital Video Colposcope (2013), cited by 5
- K880196: Laminaria (1988), cited by 1
- K880195: Gynescope (1988), cited by 1

## Recent decisions
- K143669: MedGyn Straight IUI Catheter, MedGyn Mini IUI Catheter, MedGyn curved, mini IUI Catheter (Nov 23, 2015)
- K122973: AL-106, AL-106SA and AL-106B Medgyn Digital Video Colposcope (Jun 12, 2013)
- K945179: Bottle Collection Set (Jan 26, 1995)
- K880196: Laminaria (May 6, 1988)
- K880195: Gynescope (Mar 14, 1988)

Source page: https://510kreport.com/company/medgyn-products