Bovie Medical Corporation: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Bovie Medical Corporation” (first 2006, latest 2019), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 74 days. Since 2017 the median was 51 days, against 111 days for all cleared 510(k)s in the same product codes. 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 | 2 | 121 |
| 2013 | 0 | — |
| 2014 | 2 | 68 |
| 2015 | 2 | 66 |
| 2016 | 3 | 59 |
| 2017 | 2 | 46 |
| 2018 | 1 | 55 |
| 2019 | 1 | 76 |
| 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 Bovie Medical Corporation took a median 51 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 111 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 21 | 21 |
| GEH | Unit, Cryosurgical, Accessories | 1 | 1 |
| HQP | Unit, Cautery, Thermal, Battery-Powered | 1 | 1 |
Review panels
Most recent Bovie Medical Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K183610 | Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces | GEI | 2019-03-12 | 76 |
| K180211 | Freezpoint | GEH | 2018-03-21 | 55 |
| K170777 | Bovie J-Plasma Precise FLEX Handpiece | GEI | 2017-05-01 | 47 |
| K170188 | Bovie J-Plasma Precise Open handpiece & Bovie Ultimate Gen 2 High Frequency Electrosurgical Generator | GEI | 2017-03-08 | 44 |
| K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating | GEI | 2016-07-29 | 53 |
| K161134 | Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator | GEI | 2016-06-20 | 59 |
| K152777 | Bovie Disposable Bipolar Ablator | GEI | 2016-01-15 | 112 |
| K152570 | Bovie J-Plasma Precise 360 Handpiece | GEI | 2015-11-02 | 54 |
| K151325 | Bovie J-Plasma Handpiece | GEI | 2015-08-04 | 78 |
| K142975 | Bovie Ultimate High Frequency Electrosurgical Generator | GEI | 2014-12-12 | 59 |
13 earlier clearances. See the full list in Caduvo.
Recalls
15 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2021-02-01.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Bovie Medical Corporation Dba Apyx Medical Corporation (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Bovie Medical Corporation?
FDA lists 23 510(k) clearances under the applicant name “Bovie Medical Corporation” (first 2006, latest 2019), across 3 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 Bovie Medical Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bovie Medical Corporation is 74 days. Since 2017: 51 days, versus 111 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bovie Medical Corporation?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 21); GEH (Unit, Cryosurgical, Accessories, 1); HQP (Unit, Cautery, Thermal, Battery-Powered, 1).
Next steps
- See all 23 Bovie Medical Corporation clearances with predicates and recalls
- Run predicate analysis for product code GEI, Bovie Medical Corporation'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.