Downs Surgical , Ltd.: FDA clearances and approvals
Downs Surgical , Ltd. has 60 FDA 510(k) clearances (first 1980, latest 1990), across 34 product codes in 9 review panels. Median 510(k) review time: 70 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 |
|---|---|---|---|
| HRX | Arthroscope | 10 | 10 |
| GDM | Needle, Aspiration And Injection, Reusable | 5 | 5 |
| HAO | Instrument, Surgical, Non-Powered | 5 | 5 |
| GZX | Instrument, Microsurgical | 2 | 2 |
| HCI | Applier, Aneurysm Clip | 2 | 2 |
| HDF | Speculum, Vaginal, Metal | 2 | 2 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 2 | 2 |
| EIG | Retractor, All Types | 1 | 1 |
| EMF | Knife, Surgical | 1 | 1 |
| EMH | Forceps, Rongeur, Surgical | 1 | 1 |
Plus 24 more product codes.
Review panels
- Orthopedic (18)
- General and Plastic Surgery (14)
- Neurology (11)
- Ear, Nose and Throat (3)
- Dental (2)
- Obstetrics and Gynecology (2)
- Radiology (2)
- General Hospital (1)
- Ophthalmic (1)
Most recent Downs Surgical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K903750 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E | GDM | 1990-10-31 | 76 |
| K903749 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U | GDM | 1990-10-31 | 76 |
| K903748 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V | GDM | 1990-10-31 | 76 |
| K903747 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U | GDM | 1990-10-31 | 76 |
| K900616 | SHEPPERD CUTTING FORCEPS | HRX | 1990-10-22 | 256 |
| K900615 | SHEPPERD NERVE ROOT RETRACTOR W/SUCTION & FIBRE | HRX | 1990-10-22 | 256 |
| K900614 | SHEPPERD SHORT MUSCLE RETRACTOR (GS-501-45-V) | HRX | 1990-10-22 | 256 |
| K900613 | SHEPPERD SHELTER TUBE COMPLETE & DRILL | HRX | 1990-10-22 | 256 |
| K900612 | SHEPPERD TREPHINE SET (GS-501-30-V) | HRX | 1990-10-22 | 256 |
| K900611 | SHEPPERD DILATATION TUBE SET (GS-501-20-H) | HRX | 1990-10-22 | 256 |
50 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Downs Surgical , Ltd..
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 Downs Surgical , Ltd. have?
Downs Surgical , Ltd. has 60 FDA 510(k) clearances (first 1980, latest 1990), across 34 product codes in 9 review panels.
How long does FDA take to clear Downs Surgical , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Downs Surgical , Ltd.'s cleared 510(k)s is 70 days.
What devices does Downs Surgical , Ltd. make?
Its most frequent FDA product codes are HRX (Arthroscope, 10); GDM (Needle, Aspiration And Injection, Reusable, 5); HAO (Instrument, Surgical, Non-Powered, 5).
Has Downs Surgical , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Downs Surgical , Ltd. Related entities may recall under other names.
Next steps
- See all 60 Downs Surgical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HRX, Downs Surgical , Ltd.'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.