Imagyn Medical Technologies, Inc.: FDA clearances and approvals
Imagyn Medical Technologies, Inc. has 7 FDA 510(k) clearances (first 1998, latest 2003), across 6 product codes in 5 review panels. Median 510(k) review time: 112 days.
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 |
|---|---|---|---|
| LKY | Device, External Penile Rigidity | 2 | 2 |
| DQA | Oximeter | 1 | 1 |
| DSB | Plethysmograph, Impedance | 1 | 1 |
| HCY | Curette, Uterine | 1 | 1 |
| IWJ | System, Applicator, Radionuclide, Manual | 1 | 1 |
| KXK | Source, Brachytherapy, Radionuclide | 1 | 1 |
Review panels
- Gastroenterology and Urology (2)
- Radiology (2)
- Anesthesiology (1)
- Cardiovascular (1)
- Obstetrics and Gynecology (1)
Most recent Imagyn Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K032491 | ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR | DSB | 2003-09-04 | 23 |
| K012706 | IM2001 PULSE OXIMETER | DQA | 2003-03-07 | 570 |
| K010166 | IMAGYN ISOSLEEVE / ISOSTAR NEEDLE SYSTEM | IWJ | 2001-12-03 | 319 |
| K991526 | ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501 | KXK | 1999-06-17 | 45 |
| K980096 | OAC (OPTICAL ASPIRATING CURETTE) | HCY | 1998-05-01 | 112 |
| K980291 | IMPOWER EXTERNAL VACUUM SYSTEM | LKY | 1998-03-11 | 44 |
| K974173 | ERECAID SYSTEM/STAY EREC SYSTEM | LKY | 1998-02-25 | 112 |
Recalls
openFDA lists no recalls under a recalling firm named Imagyn Medical Technologies, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Imagyn Medical Technologies, Inc. have?
Imagyn Medical Technologies, Inc. has 7 FDA 510(k) clearances (first 1998, latest 2003), across 6 product codes in 5 review panels.
How long does FDA take to clear Imagyn Medical Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Imagyn Medical Technologies, Inc.'s cleared 510(k)s is 112 days.
What devices does Imagyn Medical Technologies, Inc. make?
Its most frequent FDA product codes are LKY (Device, External Penile Rigidity, 2); DQA (Oximeter, 1); DSB (Plethysmograph, Impedance, 1).
Has Imagyn Medical Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Imagyn Medical Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 7 Imagyn Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LKY, Imagyn Medical Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.