Top Surgical Manufacturers Co.: FDA clearances and approvals
Top Surgical Manufacturers Co. has 12 FDA 510(k) clearances (first 1983, latest 1985), across 9 product codes in 5 review panels. Median 510(k) review time: 71 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 |
|---|---|---|---|
| FMF | Syringe, Piston | 3 | 3 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 1 |
| FIE | Needle, Fistula | 1 | 1 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 1 | 1 |
| GAA | Needle, Aspiration And Injection, Disposable | 1 | 1 |
| KNZ | Accessories, A-V Shunt | 1 | 1 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 1 | 1 |
Review panels
- General Hospital (6)
- Gastroenterology and Urology (3)
- Anesthesiology (1)
- Cardiovascular (1)
- General and Plastic Surgery (1)
Most recent Top Surgical Manufacturers Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K844343 | TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE | FIE | 1985-01-08 | 60 |
| K843415 | TOP HYPODERMIC SYRINGE LUER LOCK | FMF | 1984-12-07 | 98 |
| K843313 | TOP DISPOSABLE SPINAL NEEDLE | BSP | 1984-09-19 | 26 |
| K843414 | TOP HYPODERMIC SYRINGE PISTON | FMF | 1984-09-07 | 7 |
| K841119 | TOPS DISPOS. INFUSION SET/HEMODIALYSIS | KNZ | 1984-04-20 | 36 |
| K841025 | TOP DISPOSABLE INFUSION SET | FPA | 1984-03-30 | 18 |
| K832624 | TOP VENULA I.V. CATHETER SET | FOZ | 1983-11-21 | 109 |
| K832625 | TOP THREE WAY STOPCOCK | DTL | 1983-10-19 | 76 |
| K832626 | TOP STERILE DISPOS. HYPODERMIC NEEDLES | GAA | 1983-10-14 | 71 |
| K832623 | TOP DISPOS. INFUSION SET/HEMODIALY | KOC | 1983-10-14 | 71 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Top Surgical Manufacturers Co..
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 Top Surgical Manufacturers Co. have?
Top Surgical Manufacturers Co. has 12 FDA 510(k) clearances (first 1983, latest 1985), across 9 product codes in 5 review panels.
How long does FDA take to clear Top Surgical Manufacturers Co.'s 510(k)s?
The median time from FDA receipt to decision across Top Surgical Manufacturers Co.'s cleared 510(k)s is 71 days.
What devices does Top Surgical Manufacturers Co. make?
Its most frequent FDA product codes are FMF (Syringe, Piston, 3); FPA (Set, Administration, Intravascular, 2); BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 1).
Has Top Surgical Manufacturers Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Top Surgical Manufacturers Co. Related entities may recall under other names.
Next steps
- See all 12 Top Surgical Manufacturers Co. clearances with predicates and recalls
- Run predicate analysis for product code FMF, Top Surgical Manufacturers Co.'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.