Leisegang Medical, Inc.: FDA clearances and approvals
Leisegang Medical, Inc. has 10 FDA 510(k) clearances (first 1986, latest 1999), across 9 product codes in 4 review panels. Median 510(k) review time: 96 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 |
|---|---|---|---|
| HEX | Colposcope (And Colpomicroscope) | 2 | 2 |
| ESI | Polymer, Natural-Absorbable Gelatin Material | 1 | 1 |
| FSW | Light, Surgical, Endoscopic | 1 | 1 |
| GCS | Endoscope, Battery-Powered And Accessories | 1 | 1 |
| GEH | Unit, Cryosurgical, Accessories | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| HIF | Insufflator, Laparoscopic | 1 | 1 |
| HIG | Insufflator, Hysteroscopic | 1 | 1 |
Review panels
- Obstetrics and Gynecology (4)
- General and Plastic Surgery (4)
- Ear, Nose and Throat (1)
- Gastroenterology and Urology (1)
Most recent Leisegang Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K990043 | SMOOTHLASE ALEXANDRITE LASER SYSTEM | GEX | 1999-02-11 | 36 |
| K940094 | COLPOSCOPES AND ACCESSORIES | HEX | 1995-04-25 | 473 |
| K924134 | LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESS | GCS | 1993-07-02 | 318 |
| K920217 | MAX-E-VAC | GEI | 1992-07-23 | 189 |
| K914201 | LM- LAP 10 HIGH FLOW INSUFFLATOR | HIF | 1992-01-09 | 112 |
| K912789 | LM-100/200LOW FLOW INSUFFLATOR | HIG | 1991-09-20 | 87 |
| K913135 | LM-300TWIN | FSW | 1991-09-18 | 64 |
| K911212 | LM-150HT LIGHT SOURCE | ESI | 1991-05-23 | 65 |
| K902313 | LM-1Z ZOOM SCOPE | HEX | 1990-09-04 | 104 |
| K854767 | LM 1000 | GEH | 1986-01-24 | 58 |
Recalls
openFDA lists no recalls under a recalling firm named Leisegang Medical, 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 Leisegang Medical, Inc. have?
Leisegang Medical, Inc. has 10 FDA 510(k) clearances (first 1986, latest 1999), across 9 product codes in 4 review panels.
How long does FDA take to clear Leisegang Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Leisegang Medical, Inc.'s cleared 510(k)s is 96 days.
What devices does Leisegang Medical, Inc. make?
Its most frequent FDA product codes are HEX (Colposcope (And Colpomicroscope), 2); ESI (Polymer, Natural-Absorbable Gelatin Material, 1); FSW (Light, Surgical, Endoscopic, 1).
Has Leisegang Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Leisegang Medical, Inc. Related entities may recall under other names.
Next steps
- See all 10 Leisegang Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HEX, Leisegang Medical, 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.