Aslan Medical Technologies, Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Aslan Medical Technologies, Ltd.” (first 1992, latest 1998), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 44 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 7 | 7 |
| FDE | Laparoscopy Kit | 1 | 1 |
Review panels
Most recent Aslan Medical Technologies, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982287 | ASLAN SENSOR MODULAR INSTRUMENT | GCJ | 1998-08-06 | 37 |
| K954864 | ASLAN MODULAR INSTRUMENT | GCJ | 1996-02-09 | 109 |
| K952264 | ASLAN LAPRETRACT | GCJ | 1995-06-12 | 28 |
| K950924 | ASLAN KNOT PUSHER | FDE | 1995-03-14 | 13 |
| K944082 | ASLAN DUAL ACTION JAWS GRASPING FORCEPS | GCJ | 1994-09-13 | 22 |
| K926282 | MCKERNAN-POTTS GRASPING FORCEPS | GCJ | 1993-03-09 | 85 |
| K926281 | MCKERNAN-ADSON AGGRESSIVE FORCEPS | GCJ | 1993-03-09 | 85 |
| K925041 | MCKERNAN ATRAUMATIC FORCEPS | GCJ | 1992-11-25 | 51 |
Recalls
openFDA lists no recalls under a recalling firm named Aslan Medical Technologies, Ltd..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Aslan Medical Technologies, Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Aslan Medical Technologies, Ltd.” (first 1992, latest 1998), across 2 product codes in 2 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 Aslan Medical Technologies, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aslan Medical Technologies, Ltd. is 44 days.
Which FDA product codes appear under Aslan Medical Technologies, Ltd.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 7); FDE (Laparoscopy Kit, 1).
Next steps
- See all 8 Aslan Medical Technologies, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Aslan Medical Technologies, Ltd.'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.