Laurimed, LLC: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Laurimed, LLC” (first 2008, latest 2017), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 81 days. 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 | 1 | 84 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 64 |
| 2017 | 1 | 111 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 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 Laurimed, LLC took a median 111 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 142 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 3 | 3 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 3 | 3 |
| HRX | Arthroscope | 2 | 2 |
Review panels
- Anesthesiology (3)
- Ear, Nose and Throat (3)
- Orthopedic (2)
Most recent Laurimed, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K163247 | 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider | ERL | 2017-03-09 | 111 |
| K161101 | PolypVac Microdebrider (3.3mm and 4.0mm) | ERL | 2016-06-22 | 64 |
| K133133 | LAURIMED POLYPVAC MICRODEBRIDER | ERL | 2013-12-23 | 84 |
| K091818 | LAURIMED SPINAL INJECTION SYSTEM | BSP | 2009-09-23 | 97 |
| K090815 | PERCUTANEOUS DISCECTOMY SYSTEM | HRX | 2009-05-21 | 57 |
| K083909 | SPINAL INJECTION SYSTEM | BSP | 2009-03-18 | 78 |
| K082194 | LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 | HRX | 2008-08-28 | 24 |
| K080140 | LAURIMED SPINAL INJECTION SYSTEM | BSP | 2008-05-09 | 108 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2014-04-07.
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 Laurimed, LLC?
FDA lists 8 510(k) clearances under the applicant name “Laurimed, LLC” (first 2008, latest 2017), across 3 product codes in 3 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 Laurimed, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Laurimed, LLC is 81 days.
Which FDA product codes appear under Laurimed, LLC?
The most frequent FDA product codes under this applicant name are BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 3); ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, 3); HRX (Arthroscope, 2).
Next steps
- See all 8 Laurimed, LLC clearances with predicates and recalls
- Run predicate analysis for product code BSP, Laurimed, LLC'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.