Clarus Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Clarus Medical Systems, Inc.” (first 1992, latest 1998), across 13 product codes in 7 review panels. Median 510(k) review time under this name: 184 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 | 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 |
|---|---|---|---|
| GWG | Endoscope, Neurological | 7 | 7 |
| HRX | Arthroscope | 4 | 4 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| ERA | Otoscope | 1 | 1 |
| FHO | Pneumoperitoneum Needle | 1 | 1 |
| FTI | Lamp, Endoscope, Incandescent | 1 | 1 |
| GAD | Retractor | 1 | 1 |
| GBZ | Catheter, Cholangiography | 1 | 1 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| GZX | Instrument, Microsurgical | 1 | 1 |
Plus 3 more product codes.
Review panels
- Neurology (8)
- Orthopedic (4)
- Gastroenterology and Urology (3)
- General and Plastic Surgery (3)
- Ear, Nose and Throat (2)
- Cardiovascular (1)
- Ophthalmic (1)
Most recent Clarus Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K980588 | CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 | GAD | 1998-08-18 | 182 |
| K974579 | PERCSCOPE MODEL 2600 | HRX | 1998-02-18 | 72 |
| K971584 | CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) | OCV | 1997-05-23 | 23 |
| K971455 | CLARUS MODEL 5197 SIGHTLITE | FTI | 1997-05-20 | 29 |
| K960915 | CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX | GWG | 1996-12-24 | 293 |
| K962255 | CLARUS MURPHYPEN ENDOSCOPE(2127-XXX) | EOB | 1996-09-11 | 91 |
| K955598 | CLARUS SPINEPEN MODEL 2126 | GWG | 1996-02-06 | 60 |
| K953685 | INSTRUMENT SCOPE | GWG | 1995-10-12 | 66 |
| K945633 | NEURO CHANNEL ENDOSCOPE MODEL 2232 | GWG | 1995-09-19 | 307 |
| K945296 | CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160 | GWG | 1995-07-14 | 256 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Clarus Medical Systems, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Clarus Medical, LLC (10 510(k)s)
- Clarus Viewer Corporation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Clarus Medical Systems, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Clarus Medical Systems, Inc.” (first 1992, latest 1998), across 13 product codes in 7 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 Clarus Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clarus Medical Systems, Inc. is 184 days.
Which FDA product codes appear under Clarus Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are GWG (Endoscope, Neurological, 7); HRX (Arthroscope, 4); EOB (Nasopharyngoscope (Flexible Or Rigid), 1).
Next steps
- See all 22 Clarus Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GWG, Clarus Medical Systems, 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.