Peak Surgical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Peak Surgical, Inc.” (first 2008, latest 2011), across 1 product code in 1 review panel. Median 510(k) review time under this name: 150 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 | 7 | 7 |
Review panels
Most recent Peak Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103775 | PEAK SUCTION COAGULATOR | GEI | 2011-05-27 | 151 |
| K102709 | PEAK PLASMABLADE PLUS TISSUE DISSECTION DEVICE | GEI | 2010-12-17 | 88 |
| K102029 | PEAK PULSAR II GENERATOR MODEL PS100-102 | GEI | 2010-12-16 | 150 |
| K093695 | PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE | GEI | 2010-04-13 | 134 |
| K083415 | PEAK PLASMABLADE TNA TONSIL AND ADENOID TISSUE DISSECTION DEVICE | GEI | 2009-06-05 | 199 |
| K082786 | PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES | GEI | 2008-12-03 | 71 |
| K073057 | PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040 | GEI | 2008-07-22 | 266 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2009-05-19.
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.
- Peak Performance Technologies, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Peak Surgical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Peak Surgical, Inc.” (first 2008, 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 Peak Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Peak Surgical, Inc. is 150 days.
Which FDA product codes appear under Peak Surgical, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 7).
Next steps
- See all 7 Peak Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Peak Surgical, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.