Novasys Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Novasys Medical, Inc.” (first 2000, latest 2004), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 82 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| FEC | Obturator, For Endoscope | 1 | 1 |
| NVJ | Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women | 1 | 1 |
Review panels
Most recent Novasys Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042132 | NOVASYS TRANSURETHRAL RF SYSTEM | NVJ | 2004-12-21 | 134 |
| K013730 | ARIEL RADIO FREQUENCY (RF) ELECTROSURGICAL CONTROL MODULE AND ACCESSORIES | GEI | 2002-02-06 | 89 |
| K001328 | INTRODUCER SHEATH | FEC | 2000-07-17 | 82 |
| K001150 | ELECTROSURGICAL ELECTRODE FAMILY, MODEL 20-2 NEEDLE BALLOON CATHETER, MODEL 40-4 NEEDLE BALLOON CATHETER, MODEL 60-6 NEE | GEI | 2000-06-29 | 80 |
| K001151 | ELECTROSURGICAL ELECTRODE FAMILY | GEI | 2000-06-27 | 78 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2009-07-27.
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 Novasys Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Novasys Medical, Inc.” (first 2000, latest 2004), 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 Novasys Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Novasys Medical, Inc. is 82 days.
Which FDA product codes appear under Novasys Medical, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3); FEC (Obturator, For Endoscope, 1); NVJ (Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women, 1).
Next steps
- See all 5 Novasys Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Novasys Medical, Inc.'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.