Porex Surgical, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Porex Surgical, Inc.” (first 1994, latest 2011), across 12 product codes in 5 review panels. Median 510(k) review time under this name: 107 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 |
|---|---|---|---|
| HPZ | Implant, Eye Sphere | 6 | 6 |
| FWP | Prosthesis, Chin, Internal | 2 | 2 |
| NPK | Barrier, Synthetic, Intraoral | 2 | 2 |
| FTM | Mesh, Surgical | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GXP | Methyl Methacrylate For Cranioplasty | 1 | 1 |
| HBW | Fastener, Plate, Cranioplasty | 1 | 1 |
| HQN | Conformer, Ophthalmic | 1 | 1 |
| JEY | Plate, Bone | 1 | 1 |
| JOF | Polymer, Ent Synthetic, Porous Polyethylene | 1 | 1 |
Plus 2 more product codes.
Review panels
- Ophthalmic (8)
- General and Plastic Surgery (4)
- Dental (3)
- Ear, Nose and Throat (2)
- Neurology (2)
Most recent Porex Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K102184 | MEDPOR CONTAIN CAN IMPLANT | NPK | 2011-01-07 | 158 |
| K101835 | MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 | HBW | 2010-12-03 | 155 |
| K091807 | MEDPOR FIXATION SYSTEM | JEY | 2010-06-28 | 375 |
| K091120 | MEDPOR CONTAIN IMPLANT | NPK | 2010-03-19 | 336 |
| K083621 | MEDPOR CUSTOMIZED SURGICAL IMPLANT | JOF | 2009-02-03 | 57 |
| K071335 | MEDPOR ATTRACTOR IMPLANT | HPZ | 2007-08-08 | 89 |
| K052297 | POREX ELECTROSURGERY NEEDLE | GEI | 2006-03-28 | 217 |
| K040851 | MEDPOR ATTRACTOR MAGNETIC COUPLING SYSTEM | HPZ | 2004-07-16 | 107 |
| K040364 | MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH | FTM | 2004-06-30 | 138 |
| K021357 | MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT | HPZ | 2002-08-05 | 98 |
9 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2008-03-28.
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.
- Porex Medical (15 510(k)s)
- Porex Technologies Corp. (2 510(k)s)
- Porex Technologies Corp. of Georgia (2 510(k)s)
- Porex Medical Products (1 510(k)s)
- Porex Surgical Products Group (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Porex Surgical, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Porex Surgical, Inc.” (first 1994, latest 2011), across 12 product codes in 5 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 Porex Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Porex Surgical, Inc. is 107 days.
Which FDA product codes appear under Porex Surgical, Inc.?
The most frequent FDA product codes under this applicant name are HPZ (Implant, Eye Sphere, 6); FWP (Prosthesis, Chin, Internal, 2); NPK (Barrier, Synthetic, Intraoral, 2).
Next steps
- See all 19 Porex Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HPZ, Porex 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, 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.