Porges Corp.: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “Porges Corp.” (first 1988, latest 1990), across 11 product codes in 1 review panel. Median 510(k) review time under this name: 75 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 7 | 7 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 2 | 2 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FDX | Endoscopic Cytology Brush | 1 | 1 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 1 | 1 |
| GCP | Endoscope, Ac-Powered And Accessories | 1 | 1 |
| KGE | Forceps, Biopsy, Electric | 1 | 1 |
| KNQ | Dilator, Esophageal | 1 | 1 |
| KNY | Accessories, Catheter, G-U | 1 | 1 |
| KOB | Catheter, Suprapubic (And Accessories) | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Porges Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K900269 | PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGE | FFL | 1990-07-03 | 166 |
| K900031 | MODIFIED PEDIATRIC SILICONE FOLEY CATHETERS | KNY | 1990-03-06 | 61 |
| K896505 | PORGES UNIVERSAL HANDLES | GCP | 1990-01-30 | 76 |
| K896503 | PORGES ERCP CATHETERS | FGE | 1990-01-30 | 76 |
| K896507 | PORGES DIATHERMY SNARE | KNS | 1990-01-29 | 75 |
| K896425 | PORGES CYTOLOGY BRUSHES | FDX | 1990-01-29 | 82 |
| K896506 | PORGES ENDOSCOPIC DORMIA EXTRACTORS, DORMIATRIPTOR | FGE | 1990-01-26 | 72 |
| K896504 | PORGES 2-WAY BALLOON EXTRACTION CATHETER | FGE | 1990-01-26 | 72 |
| K896424 | PORGES SCLEROTHERAPY NEEDLES | FBK | 1990-01-26 | 79 |
| K896502 | PORGES BIOPSY & FOREIGN BODY FORCEPS | OCZ | 1990-01-22 | 68 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Porges 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.
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.
- Porges S.A. (4 510(k)s)
- Porges Catheter Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Porges Corp.?
FDA lists 18 510(k) clearances under the applicant name “Porges Corp.” (first 1988, latest 1990), across 11 product codes 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 Porges Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Porges Corp. is 75 days.
Which FDA product codes appear under Porges Corp.?
The most frequent FDA product codes under this applicant name are FGE (Stents, Drains And Dilators For The Biliary Ducts, 7); KNS (Unit, Electrosurgical, Endoscopic (With Or Without Accessories), 2); FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 1).
Next steps
- See all 18 Porges Corp. clearances with predicates and recalls
- Run predicate analysis for product code FGE, Porges 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.