Porges Corp.: FDA clearances and approvals
Porges Corp. has 18 FDA 510(k) clearances (first 1988, latest 1990), across 11 product codes in 1 review panel. Median 510(k) review time: 75 days.
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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Porges Corp. have?
Porges Corp. has 18 FDA 510(k) clearances (first 1988, latest 1990), across 11 product codes in 1 review panel.
How long does FDA take to clear Porges Corp.'s 510(k)s?
The median time from FDA receipt to decision across Porges Corp.'s cleared 510(k)s is 75 days.
What devices does Porges Corp. make?
Its most frequent FDA product codes 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).
Has Porges Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Porges Corp. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.