Emcision , Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Emcision , Ltd.” (first 2005, latest 2018), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 65 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 | 1 | 167 |
| 2016 | 1 | 58 |
| 2017 | 0 | — |
| 2018 | 1 | 57 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Emcision , Ltd. took a median 57 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 112 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 7 | 7 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 3 | 3 |
Review panels
Most recent Emcision , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180165 | Habib EndoHPB | KNS | 2018-03-20 | 57 |
| K161305 | Habib EUS RFA | GEI | 2016-07-07 | 58 |
| K150029 | Habib EUS RFA | GEI | 2015-06-24 | 167 |
| K083292 | HABIB ENDOHPB | KNS | 2009-06-10 | 212 |
| K080717 | HABIB HEXABLATE 10 | GEI | 2008-03-27 | 14 |
| K073687 | HABIB LAPAROSCOPIC HEXABLATE | GEI | 2008-01-09 | 12 |
| K072383 | HABIB ENDOBLATE | KNS | 2007-11-29 | 97 |
| K072126 | HABIB VESEAL | GEI | 2007-10-02 | 61 |
| K071103 | HABIB HEXABLATE | GEI | 2007-06-27 | 69 |
| K051420 | HABIB 4X | GEI | 2005-08-15 | 75 |
Recalls
openFDA lists no recalls under a recalling firm named Emcision , 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 Emcision , Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Emcision , Ltd.” (first 2005, latest 2018), 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 Emcision , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Emcision , Ltd. is 65 days.
Which FDA product codes appear under Emcision , Ltd.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 7); KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), 3).
Next steps
- See all 10 Emcision , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Emcision , 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.