Surgi-Quip Inc.U: FDA clearances and approvals
Surgi-Quip Inc.U has 8 FDA 510(k) clearances (first 1982, latest 1984), across 7 product codes in 3 review panels. Median 510(k) review time: 36 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 |
|---|---|---|---|
| HBN | Chair, Neurosurgical | 2 | 2 |
| EPT | Microscope, Surgical | 1 | 1 |
| FQO | Table, Operating-Room, Ac-Powered | 1 | 1 |
| FSE | Table, Operating-Room, Manual | 1 | 1 |
| FWX | Table, Operating-Room, Mechanical | 1 | 1 |
| LCC | Applicator, Ocular Pressure | 1 | 1 |
Plus 1 more product codes.
Review panels
- General and Plastic Surgery (4)
- Neurology (2)
- Ophthalmic (1)
Most recent Surgi-Quip Inc.U 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841116 | MOBILE OPHTHALMIC OPERATING TABLE | FWX | 1984-05-09 | 55 |
| K841115 | CHARLES/MCINTYRE GIANT BREAK TABLE | FQO | 1984-05-09 | 55 |
| K840004 | WEE BAG O'MERCURY | LCC | 1984-03-22 | 78 |
| K832887 | ELECTRONIC UNIT | EPT | 1983-10-04 | 39 |
| K822554 | CEMENT EXTRACTION INSTRUMENTATION | — | 1982-09-14 | 21 |
| K822427 | SELF-CONTAINED MOBILE OPHTHAL. OPER. . | FSE | 1982-09-14 | 33 |
| K822428 | SURGI-QUIP MICROSCOPE STAND | HBN | 1982-09-02 | 21 |
| K822426 | MCINTYRE MICROSCOPE STAND | HBN | 1982-09-02 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Surgi-Quip Inc.U.
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 Surgi-Quip Inc.U have?
Surgi-Quip Inc.U has 8 FDA 510(k) clearances (first 1982, latest 1984), across 7 product codes in 3 review panels.
How long does FDA take to clear Surgi-Quip Inc.U's 510(k)s?
The median time from FDA receipt to decision across Surgi-Quip Inc.U's cleared 510(k)s is 36 days.
What devices does Surgi-Quip Inc.U make?
Its most frequent FDA product codes are HBN (Chair, Neurosurgical, 2); EPT (Microscope, Surgical, 1); FQO (Table, Operating-Room, Ac-Powered, 1).
Has Surgi-Quip Inc.U had device recalls?
openFDA lists no recalls under a recalling firm name matching Surgi-Quip Inc.U. Related entities may recall under other names.
Next steps
- See all 8 Surgi-Quip Inc.U clearances with predicates and recalls
- Run predicate analysis for product code HBN, Surgi-Quip Inc.U'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.