Healthtronics Surgical Services, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Healthtronics Surgical Services, Inc.” (first 1988, latest 2001), plus 1 PMA decision, across 2 product codes in 2 review panels. Median 510(k) review time under this name: 68 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 |
|---|---|---|---|
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | 2 | 1 |
| JFB | Table, Physical Therapy, Multi Function | 1 | 1 |
Review panels
Most recent Healthtronics Surgical Services, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K012785 | TWINTRODE ELC 134 ELECTRODE | LNS | 2001-11-16 | 88 |
| K881902 | HEALTHTRONIC OMEGA TRAC | JFB | 1988-06-22 | 47 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P970019 | PMA | HEALTHTRONICS LITHOTRON LIHTOTRIPSY SYSTEM | 1997-07-21 |
Recalls
openFDA lists no recalls under a recalling firm named Healthtronics Surgical Services, 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.
- Healthtronics (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Healthtronics Surgical Services, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Healthtronics Surgical Services, Inc.” (first 1988, latest 2001), plus 1 PMA decision, across 2 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 Healthtronics Surgical Services, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Healthtronics Surgical Services, Inc. is 68 days.
Which FDA product codes appear under Healthtronics Surgical Services, Inc.?
The most frequent FDA product codes under this applicant name are LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological, 2); JFB (Table, Physical Therapy, Multi Function, 1).
Next steps
- See all 2 Healthtronics Surgical Services, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNS, Healthtronics Surgical Services, 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.