A.M. Surgical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “A.M. Surgical, Inc.” (first 1998, latest 2019), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 82 days. Since 2017 the median was 106 days, against 105 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 126 |
| 2019 | 2 | 82 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name A.M. Surgical, Inc. took a median 106 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EMF | Knife, Surgical | 2 | 2 |
| HRX | Arthroscope | 1 | 1 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | 1 | 1 |
Review panels
Most recent A.M. Surgical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191771 | SECURE Screw | HWC | 2019-10-16 | 106 |
| K191345 | Pegasus System | HRX | 2019-07-17 | 58 |
| K180087 | A.M. Surgical Intramedullary Fixation Device | HTY | 2018-05-18 | 126 |
| K080133 | MOUNTABLE ENDOSCOPIC BLADE | EMF | 2008-03-13 | 55 |
| K042458 | A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM | LXT | 2004-10-07 | 27 |
| K982142 | MOUNTABLE ENDOSCOPIC KNIFE | EMF | 1998-12-30 | 196 |
Recalls
openFDA lists no recalls under a recalling firm named A.M. Surgical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under A.M. Surgical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “A.M. Surgical, Inc.” (first 1998, latest 2019), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by A.M. Surgical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name A.M. Surgical, Inc. is 82 days. Since 2017: 106 days, versus 105 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under A.M. Surgical, Inc.?
The most frequent FDA product codes under this applicant name are EMF (Knife, Surgical, 2); HRX (Arthroscope, 1); HTY (Pin, Fixation, Smooth, 1).
Next steps
- See all 6 A.M. Surgical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EMF, A.M. Surgical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.