Ellman Int'L, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ellman Int'L, Inc.” (first 2005, latest 2011), across 1 product code in 1 review panel. Median 510(k) review time under this name: 84 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 | 6 | 6 |
Review panels
Most recent Ellman Int'L, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102698 | PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFE | GEI | 2011-01-05 | 107 |
| K102368 | NON-ABLATIVE WRINKLE TREATMENT HANDPIECE | GEI | 2010-09-07 | 18 |
| K101967 | NON-ABLATIVE WRINKLE TREATENT HANDPIECE MODLE PELLEVE' | GEI | 2010-08-12 | 30 |
| K082834 | ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC | GEI | 2009-05-07 | 223 |
| K061174 | SURGI-MAX | GEI | 2006-06-28 | 62 |
| K042710 | SURGITRON RADIOLASE II | GEI | 2005-04-07 | 189 |
Recalls
openFDA lists no recalls under a recalling firm named Ellman Int'L, Inc..
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.
- Ellman Intl., Inc. (15 510(k)s)
- Ellman International, Inc. (5 510(k)s)
- Ellman Intl. Mfg., Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ellman Int'L, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Ellman Int'L, Inc.” (first 2005, latest 2011), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ellman Int'L, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ellman Int'L, Inc. is 84 days.
Which FDA product codes appear under Ellman Int'L, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 6).
Next steps
- See all 6 Ellman Int'L, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Ellman Int'L, 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.