Phx Technologies Corp.: FDA filings under this applicant name
FDA lists 49 510(k) clearances under the applicant name “Phx Technologies Corp.” (first 1993, latest 1998), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 122 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 33 | 33 |
| HRX | Arthroscope | 10 | 10 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope | 1 | 1 |
| FHQ | Holder, Needle, Gastroenterologic | 1 | 1 |
| GCL | Esophagoscope, General & Plastic Surgery | 1 | 1 |
| OCZ | Endoscopic Grasping/Cutting Instrument, Non-Powered | 1 | 1 |
Review panels
Most recent Phx Technologies Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974327 | WINGED NEEDLE HOLDER | FHQ | 1998-01-09 | 52 |
| K971123 | STONE EXTRACTOR | OCZ | 1997-06-27 | 92 |
| K954510 | RRIANGLE KNIFE | HRX | 1995-11-14 | 47 |
| K954509 | PROBE KNIFE | HRX | 1995-11-14 | 47 |
| K954508 | RETRACTOR | HRX | 1995-11-14 | 47 |
| K954507 | RETROGRADE KNIFE | HRX | 1995-11-14 | 47 |
| K954476 | PROBE | HRX | 1995-10-23 | 27 |
| K954475 | BLUNT DISSECTOR, CURVED | HRX | 1995-10-23 | 27 |
| K954464 | CARPAL TUNNEL SLOTTED CANNULA | HRX | 1995-10-23 | 28 |
| K954463 | DISSECTING OBTURATOR | HRX | 1995-10-23 | 28 |
39 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Phx Technologies Corp..
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 Phx Technologies Corp.?
FDA lists 49 510(k) clearances under the applicant name “Phx Technologies Corp.” (first 1993, latest 1998), across 7 product codes in 3 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 Phx Technologies Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Phx Technologies Corp. is 122 days.
Which FDA product codes appear under Phx Technologies Corp.?
The most frequent FDA product codes under this applicant name are GCJ (Laparoscope, General & Plastic Surgery, 33); HRX (Arthroscope, 10); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2).
Next steps
- See all 49 Phx Technologies Corp. clearances with predicates and recalls
- Run predicate analysis for product code GCJ, Phx Technologies Corp.'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.