Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Imagyn Medical, Inc. · Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
123 daysmedian FDA review time
183 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972426 | MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEAT | Imagyn Medical, Inc. | 1997-09-23 | 88 | 0 |
| K970750 | MICROSPAN INSEMINATION SYSTEM | Imagyn Medical, Inc. | 1997-05-05 | 63 | 0 |
| K971255 | IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER | Imagyn Medical, Inc. | 1997-04-21 | 17 | 0 |
| K965055 | IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES | Imagyn Medical, Inc. | 1997-03-06 | 78 | 0 |
| K963580 | IMAGYN FALLOPOSCOPY SYSTEM | Imagyn Medical, Inc. | 1997-01-31 | 147 | 0 |
| K961688 | MICROSPAN HYSTEROSCOPE | Imagyn Medical, Inc. | 1996-10-15 | 167 | 0 |
| K961506 | MICROSPAN HYSTEROSCOPE SHEATH | Imagyn Medical, Inc. | 1996-07-03 | 75 | 0 |
| K952032 | IMAGYN HYSTEROSCOPE SHEATHS | Imagyn Medical, Inc. | 1995-10-31 | 183 | 0 |
| K951996 | IMAGYN ENDOSCOPE | Imagyn Medical, Inc. | 1995-09-01 | 126 | 0 |
| K951974 | IMAGYN ENDOSCOPE SHEATH | Imagyn Medical, Inc. | 1995-08-28 | 123 | 0 |
| K953201 | IMAGYN UROSCOPE | Imagyn Medical, Inc. | 1995-08-02 | 27 | 0 |
| K952033 | IMAGYN HYSTEROSCOPE | Imagyn Medical, Inc. | 1995-07-24 | 84 | 0 |
| K945131 | IMAGYN INTRAUTERINE INSEMINATION DEVICE | Imagyn Medical, Inc. | 1995-05-15 | 208 | 0 |
| K943810 | IMAGYN MICROLAP INTRODUCER | Imagyn Medical, Inc. | 1995-01-26 | 174 | 0 |
| K944079 | IMAGYN MICROLAP(TM) LAPAROSCOPE | Imagyn Medical, Inc. | 1995-01-20 | 151 | 0 |
| K944129 | IMAGYN LAPAROSCOPIC INSTRUMENTS | Imagyn Medical, Inc. | 1994-10-20 | 57 | 0 |
| K940425 | IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE T | Imagyn Medical, Inc. | 1994-08-01 | 182 | 0 |
| K931518 | IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP & ACCE | Imagyn Medical, Inc. | 1993-08-18 | 145 | 0 |
| K911163 | IMAGYN MEDICAL VIDEOSCOPY SYST W/IRRIG PUMP/ACCESS | Imagyn Medical, Inc. | 1991-06-03 | 80 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda