Amsco Co.: FDA clearances and approvals
Amsco Co. has 19 FDA 510(k) clearances (first 1977, latest 1992), across 15 product codes in 4 review panels. Median 510(k) review time: 37 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 |
|---|---|---|---|
| GET | Motor, Surgical Instrument, Pneumatic Powered | 4 | 4 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 2 | 2 |
| ETF | Unit, Examining/Treatment, Ent | 1 | 1 |
| FLE | Sterilizer, Steam | 1 | 1 |
| FLF | Sterilizer, Ethylene-Oxide Gas | 1 | 1 |
| FLI | Cabinet, Ethylene-Oxide Gas Aerator | 1 | 1 |
| FQO | Table, Operating-Room, Ac-Powered | 1 | 1 |
| FQP | Lamp, Operating-Room | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| FSY | Light, Surgical, Ceiling Mounted | 1 | 1 |
Plus 5 more product codes.
Review panels
- General and Plastic Surgery (11)
- General Hospital (6)
- Ear, Nose and Throat (1)
- Obstetrics and Gynecology (1)
Most recent Amsco Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K912471 | EAGLE 3000 SDS | FLE | 1992-06-26 | 388 |
| K854922 | AMSCO POLARIS SL | FSY | 1986-01-24 | 45 |
| K833187 | HALL OSTEON | GET | 1983-10-31 | 42 |
| K832945 | EAGLE 2000 STERILIZER SERIES GAS/AERA | FLF | 1983-10-19 | 50 |
| K832188 | HALL RECIPROCATOR | GET | 1983-08-12 | 37 |
| K832187 | HALL OSCILLATOR | GET | 1983-08-12 | 37 |
| K832186 | HALL DRILL/REAMER | GET | 1983-08-12 | 37 |
| K831086 | CEILING MOUNTED SUPPORT | FQO | 1983-08-12 | 130 |
| K831309 | DELIVERY 4 TABLE | KNC | 1983-06-15 | 54 |
| K823360 | SURGICAL LIGHT | FTD | 1982-12-03 | 28 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Amsco 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 Amsco Co. have?
Amsco Co. has 19 FDA 510(k) clearances (first 1977, latest 1992), across 15 product codes in 4 review panels.
How long does FDA take to clear Amsco Co.'s 510(k)s?
The median time from FDA receipt to decision across Amsco Co.'s cleared 510(k)s is 37 days.
What devices does Amsco Co. make?
Its most frequent FDA product codes are GET (Motor, Surgical Instrument, Pneumatic Powered, 4); JOJ (Indicator, Physical/Chemical Sterilization Process, 2); ETF (Unit, Examining/Treatment, Ent, 1).
Has Amsco Co. had device recalls?
openFDA lists no recalls under a recalling firm name matching Amsco Co. Related entities may recall under other names.
Next steps
- See all 19 Amsco Co. clearances with predicates and recalls
- Run predicate analysis for product code GET, Amsco 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.