Encision, Inc.: FDA clearances and approvals
Encision, Inc. has 10 FDA 510(k) clearances (first 2007, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time: 89 days. openFDA lists 26 product recalls by a recalling firm named Encision, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 78 |
| 2013 | 2 | 108 |
| 2014 | 1 | 165 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 89 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Encision, Inc.'s cleared 510(k)s took a median 89 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 9 | 9 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
Review panels
Most recent Encision, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201018 | Encision AEM enTouch 2X Scissor | GEI | 2020-07-15 | 89 |
| K140006 | ENDOSHIELD BURN PROTECTION SYSTEM | GEI | 2014-06-16 | 165 |
| K131949 | AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES | GEI | 2013-08-26 | 60 |
| K122383 | EM3 AEM MONITOR AEM CONNECTORS | GEI | 2013-01-10 | 157 |
| K122580 | AEM DISPOSABLE SUCTION IRRIGATION HANDSET MODEL ES1700; AEM DISPOSABLE SUCTION IRRIGATION ELECTRODES MODEL ES077X SERIES | GEI | 2012-11-09 | 78 |
| K093622 | AEM MONITORING SYSTEM, MODELS EM2, EMR, ES4007, ES4107, ES9005 AND ES9015 | GEI | 2010-08-20 | 270 |
| K100711 | SUCTION IRRIGATION ELECTRODES AND ADAPTERS | GEI | 2010-06-09 | 89 |
| K091074 | AEM DISPOSABLE ELECTRODES,MODEL ESO300 SERIES | GEI | 2009-08-17 | 125 |
| K090979 | DISPOSABLE HANDLE ASSEMBLES, MODELS DH0100 AND DH0500 SERIES | GCJ | 2009-05-28 | 51 |
| K072789 | DISPOSABLE AEM FIXED TIP ELECTRODES AND HANDPIECES | GEI | 2007-10-19 | 18 |
Recalls
26 product recalls in 8 recall events; 0 initiated in the last five years. Most recent: 2012-06-15.
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 Encision, Inc. have?
Encision, Inc. has 10 FDA 510(k) clearances (first 2007, latest 2020), across 2 product codes in 1 review panel.
How long does FDA take to clear Encision, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Encision, Inc.'s cleared 510(k)s is 89 days.
What devices does Encision, Inc. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 9); GCJ (Laparoscope, General & Plastic Surgery, 1).
Has Encision, Inc. had device recalls?
openFDA lists 26 product recalls in 8 recall events by a recalling firm whose name matches Encision, Inc; the most recent began 2012-06-15. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 10 Encision, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Encision, 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.