# Imagyn Medical, Inc.

- Location (FDA's records): Laguna Niguel, CA
- FDA decisions: 19 (1991–1997): 19 510(k) clearances
- Product codes: HIH (5), HET (5), GCJ (3), MAV (1), HDR (1), MKO (1), FAJ (1), FWF (1), MFD (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 13 (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 that cite its devices most
- Medworks Corp.: 3 (https://510kreport.com/company/medworks)
- United States Surgical, A Division of Tyco Healthc: 2 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- Gimmi GmbH: 1 (https://510kreport.com/company/gimmi)
- Fem Suite, LLC: 1 (https://510kreport.com/company/fem-suite)
- Innerdyne, Inc.: 1 (https://510kreport.com/company/innerdyne)
- Omnisonics Medical Technologies: 1 (https://510kreport.com/company/omnisonics-medical-technologies)
- Imagyn Medical Technologies, Inc.: 1 (https://510kreport.com/company/imagyn-medical-technologies)
- Aesculap, Inc.: 1 (https://510kreport.com/company/aesculap)

## Its most-cited devices
- K961688: Microspan Hysteroscope (1996), cited by 4
- K965055: Imagyn Microlap and Micro Lap-Gold Laparoscopes (1997), cited by 2
- K944079: Imagyn Microlap (TM) Laparoscope (1995), cited by 2
- K943810: Imagyn Microlap Introducer (1995), cited by 1
- K961506: Microspan Hysteroscope Sheath (1996), cited by 1
- K972426: Microspan Gold Hysteroscope and Microspan Hysteroscope Sheath (1997), cited by 1

## Recent decisions
- K972426: Microspan Gold Hysteroscope and Microspan Hysteroscope Sheath (Sep 23, 1997)
- K970750: Microspan Insemination System (May 5, 1997)
- K971255: Imagyn Expandable Laparoscopic Introducer (Apr 21, 1997)
- K965055: Imagyn Microlap and Micro Lap-Gold Laparoscopes (Mar 6, 1997)
- K963580: Imagyn Falloposcopy System (Jan 31, 1997)
- K961688: Microspan Hysteroscope (Oct 15, 1996)
- K961506: Microspan Hysteroscope Sheath (Jul 3, 1996)
- K952032: Imagyn Hysteroscope Sheaths (Oct 31, 1995)

Source page: https://510kreport.com/company/imagyn-medical