Company ยท US
Imagyn Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 1997. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | 5 |
| HIH | Hysteroscope (And Accessories) | 5 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 |
| FWF | Camera, Television, Endoscopic, Without Audio | 1 |
| HDR | Cap, Cervical | 1 |
| MAV | Syringe, Balloon Inflation | 1 |
| MFD | Cannula, Intrauterine Insemination | 1 |
| MKO | Falloposcope | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 23, 1997 | K972426 | MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH Imagyn Medical, Inc. | HIH |
| May 5, 1997 | K970750 | MICROSPAN INSEMINATION SYSTEM Imagyn Medical, Inc. | MFD |
| Apr 21, 1997 | K971255 | IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER Imagyn Medical, Inc. | HET |
| Mar 6, 1997 | K965055 | IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES Imagyn Medical, Inc. | HET |
| Jan 31, 1997 | K963580 | IMAGYN FALLOPOSCOPY SYSTEM Imagyn Medical, Inc. | MKO |
| Oct 15, 1996 | K961688 | MICROSPAN HYSTEROSCOPE Imagyn Medical, Inc. | HIH |
| Jul 3, 1996 | K961506 | MICROSPAN HYSTEROSCOPE SHEATH Imagyn Medical, Inc. | HIH |
| Oct 31, 1995 | K952032 | IMAGYN HYSTEROSCOPE SHEATHS Imagyn Medical, Inc. | HIH |
| Sep 1, 1995 | K951996 | IMAGYN ENDOSCOPE Imagyn Medical, Inc. | GCJ |
| Aug 28, 1995 | K951974 | IMAGYN ENDOSCOPE SHEATH Imagyn Medical, Inc. | GCJ |
| Aug 2, 1995 | K953201 | IMAGYN UROSCOPE Imagyn Medical, Inc. | FAJ |
| Jul 24, 1995 | K952033 | IMAGYN HYSTEROSCOPE Imagyn Medical, Inc. | HIH |
| May 15, 1995 | K945131 | IMAGYN INTRAUTERINE INSEMINATION DEVICE Imagyn Medical, Inc. | HDR |
| Jan 26, 1995 | K943810 | IMAGYN MICROLAP INTRODUCER Imagyn Medical, Inc. | HET |
| Jan 20, 1995 | K944079 | IMAGYN MICROLAP(TM) LAPAROSCOPE Imagyn Medical, Inc. | HET |
| Oct 20, 1994 | K944129 | IMAGYN LAPAROSCOPIC INSTRUMENTS Imagyn Medical, Inc. | HET |
| Aug 1, 1994 | K940425 | IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING Imagyn Medical, Inc. | MAV |
| Aug 18, 1993 | K931518 | IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCE Imagyn Medical, Inc. | GCJ |
| Jun 3, 1991 | K911163 | IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS Imagyn Medical, Inc. | FWF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||