Imagyn Medical, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Imagyn Medical, Inc.” (first 1991, latest 1997), across 9 product codes in 4 review panels. Median 510(k) review time under this name: 123 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | 5 | 5 |
| HIH | Hysteroscope (And Accessories) | 5 | 5 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FWF | Camera, Television, Endoscopic, Without Audio | 1 | 1 |
| HDR | Cap, Cervical | 1 | 1 |
| MAV | Syringe, Balloon Inflation | 1 | 1 |
| MFD | Cannula, Intrauterine Insemination | 1 | 1 |
| MKO | Falloposcope | 1 | 1 |
Review panels
- Obstetrics and Gynecology (13)
- General and Plastic Surgery (4)
- Cardiovascular (1)
- Gastroenterology and Urology (1)
Most recent Imagyn Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972426 | MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH | HIH | 1997-09-23 | 88 |
| K970750 | MICROSPAN INSEMINATION SYSTEM | MFD | 1997-05-05 | 63 |
| K971255 | IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER | HET | 1997-04-21 | 17 |
| K965055 | IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES | HET | 1997-03-06 | 78 |
| K963580 | IMAGYN FALLOPOSCOPY SYSTEM | MKO | 1997-01-31 | 147 |
| K961688 | MICROSPAN HYSTEROSCOPE | HIH | 1996-10-15 | 167 |
| K961506 | MICROSPAN HYSTEROSCOPE SHEATH | HIH | 1996-07-03 | 75 |
| K952032 | IMAGYN HYSTEROSCOPE SHEATHS | HIH | 1995-10-31 | 183 |
| K951996 | IMAGYN ENDOSCOPE | GCJ | 1995-09-01 | 126 |
| K951974 | IMAGYN ENDOSCOPE SHEATH | GCJ | 1995-08-28 | 123 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Imagyn Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Imagyn Medical Technologies, Inc. (7 510(k)s)
- Imagyn Surgical (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Imagyn Medical, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Imagyn Medical, Inc.” (first 1991, latest 1997), across 9 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Imagyn Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Imagyn Medical, Inc. is 123 days.
Which FDA product codes appear under Imagyn Medical, Inc.?
The most frequent FDA product codes under this applicant name are HET (Laparoscope, Gynecologic (And Accessories), 5); HIH (Hysteroscope (And Accessories), 5); GCJ (Laparoscope, General & Plastic Surgery, 3).
Next steps
- See all 19 Imagyn Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HET, Imagyn Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.