Ellman International, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Ellman International, Inc.” (first 2006, latest 2014), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 191 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 | 2 | 142 |
| 2014 | 1 | 154 |
| 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 |
| HRX | Arthroscope | 1 | 1 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 1 | 1 |
Review panels
Most recent Ellman International, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K132949 | PELLEFIRM | PBX | 2014-02-20 | 154 |
| K132665 | PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IEC | GEI | 2013-09-25 | 29 |
| K123366 | SURGITRON 4.0 DUAL RF S5-IEC | GEI | 2013-07-12 | 254 |
| K071343 | ELLMAN NOBLE ALLOY ELECTRODES | GEI | 2008-02-28 | 290 |
| K052241 | DISC-FX SYSTEM | HRX | 2006-02-24 | 191 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2016-09-07.
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.
Device clinical trials
An industry sponsor named Ellman International, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01299090: Prospective Pellevé™ Neck Wrinkle Study (Completed, started 2010-11)
- NCT01299103: Safety and Efficacy of Single Therapy Versus Double and Triple Therapy of the Pellevé™ Wrinkle Treatment System for the Treatment of Moderate Facial Wrinkles (Completed, started 2010-04)
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.
- Ellman Intl., Inc. (15 510(k)s)
- Ellman Int'L, Inc. (6 510(k)s)
- Ellman Intl. Mfg., Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ellman International, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Ellman International, Inc.” (first 2006, latest 2014), 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 Ellman International, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ellman International, Inc. is 191 days.
Which FDA product codes appear under Ellman International, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3); HRX (Arthroscope, 1); PBX (Massager, Vacuum, Radio Frequency Induced Heat, 1).
Next steps
- See all 5 Ellman International, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Ellman International, 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.