Valley Forge Scientific Corp.: FDA clearances and approvals
Valley Forge Scientific Corp. has 27 FDA 510(k) clearances (first 1980, latest 2005), across 12 product codes in 6 review panels. Median 510(k) review time: 44 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 16 | 16 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| EKZ | Unit, Electrosurgical, And Accessories, Dental | 1 | 1 |
| FZM | Stool, Operating-Room | 1 | 1 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 1 | 1 |
| GXD | Generator, Lesion, Radiofrequency | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 1 | 1 |
| HJH | Loupe, Binocular, Low Power | 1 | 1 |
| HQO | Unit, Cautery, Thermal, Ac-Powered | 1 | 1 |
Plus 2 more product codes.
Review panels
- General and Plastic Surgery (18)
- Neurology (3)
- Ophthalmic (2)
- Anesthesiology (1)
- Dental (1)
- Obstetrics and Gynecology (1)
Most recent Valley Forge Scientific Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050364 | MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM | GEI | 2005-03-09 | 23 |
| K042604 | VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS | GEI | 2004-10-22 | 28 |
| K032601 | STRYKER INTERVENTIONAL PAIN RF GENERATOR | GXD | 2004-04-01 | 220 |
| K033499 | MALIS IRRIGATION MODULE 1000 | GEI | 2003-11-28 | 23 |
| K982229 | BI-DENT | EKZ | 1998-08-13 | 90 |
| K973554 | VALLEY FORGE BIPOLAR BALL TIP ELECTRODE | JOS | 1997-12-19 | 91 |
| K971986 | VALLEY FORGE BIPOLAR LOOP | HGI | 1997-08-26 | 89 |
| K964143 | MINI-SYMM BIPOLAR COAGULATOR | GEI | 1997-01-09 | 84 |
| K955764 | VALLEY FORGE BIPLOAR LOOP | GEI | 1996-03-01 | 72 |
| K955346 | VFS - 300 BIPOLAR ELECTROSURGERY SYSTEM | GEI | 1995-12-08 | 17 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Valley Forge Scientific 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 Valley Forge Scientific Corp. have?
Valley Forge Scientific Corp. has 27 FDA 510(k) clearances (first 1980, latest 2005), across 12 product codes in 6 review panels.
How long does FDA take to clear Valley Forge Scientific Corp.'s 510(k)s?
The median time from FDA receipt to decision across Valley Forge Scientific Corp.'s cleared 510(k)s is 44 days.
What devices does Valley Forge Scientific Corp. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 16); BTM (Ventilator, Emergency, Manual (Resuscitator), 1); EKZ (Unit, Electrosurgical, And Accessories, Dental, 1).
Has Valley Forge Scientific Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Valley Forge Scientific Corp. Related entities may recall under other names.
Next steps
- See all 27 Valley Forge Scientific Corp. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Valley Forge Scientific 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.