Clarus Medical Systems, Inc.
Minneapolis, MN, US
Clarus Medical Systems, Inc. appears in FDA device records in Minneapolis, MN. FDA records list 22 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 22
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 22 510(k) clearances for Clarus Medical Systems, Inc. between 1992 and 1998. The busiest year on record is 1993, with 5. The most recent is 1998, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 2 |
| 1993 | 5 |
| 1994 | 3 |
| 1995 | 5 |
| 1996 | 3 |
| 1997 | 2 |
| 1998 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K980588 | CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 | GAD | Substantially Equivalent | |
| K974579 | PERCSCOPE MODEL 2600 | HRX | Substantially Equivalent | |
| K971584 | CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) | OCV | Substantially Equivalent | |
| K971455 | CLARUS MODEL 5197 SIGHTLITE | FTI | Substantially Equivalent | |
| K960915 | CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX | GWG | Substantially Equivalent | |
| K962255 | CLARUS MURPHYPEN ENDOSCOPE(2127-XXX) | EOB | Substantially Equivalent | |
| K955598 | CLARUS SPINEPEN MODEL 2126 | GWG | Substantially Equivalent | |
| K953685 | INSTRUMENT SCOPE | GWG | Substantially Equivalent | |
| K945633 | NEURO CHANNEL ENDOSCOPE MODEL 2232 | GWG | Substantially Equivalent | |
| K945296 | CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160 | GWG | Substantially Equivalent | |
| K941188 | CLARUS NEURO ENDOSCOPE (MODEL 2230) | HRX | Substantially Equivalent | |
| K940144 | CLARUS PHOENIX ENDOSCOPE | HRX | Substantially Equivalent | |
| K942413 | CLARUS ENDOSCOPIC NEUROLOGICAL TISSUE ELEVATOR | GWG | Substantially Equivalent | |
| K942249 | CLARUS NEUROPEN MODEL 2120 | GWG | Substantially Equivalent | |
| K923514 | CLARUS SERIES 2100 ENDOSCOPE | HRX | Substantially Equivalent | |
| K932259 | CLARUS MODEL 2240 SEMI-RIGID OTOSCOPE | ERA | Substantially Equivalent | |
| K925741 | CLARUS ENDOSCOPIC HOOK KNIFE | HLX | Substantially Equivalent | |
| K925742 | CLARUS CHOLANGIOGRAM CATHETER KIT | GBZ | Unknown | |
| K926048 | CLARUS ENDOSCOPIC BALL PROBE | GZX | Substantially Equivalent | |
| K924554 | CLARUS SERIRS 2200 SEMI-RIGID ENDOSCOPE | LYK | Substantially Equivalent | |
| K922881 | CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC | GEX | Unknown | |
| K915725 | CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE | FHO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LYKAngioscope
- HRXArthroscope
- GBZCatheter, Cholangiography
- OCVEndoscope Holder
- GWGEndoscope, Neurological
- GZXInstrument, Microsurgical
- FTILamp, Endoscope, Incandescent
- EOBNasopharyngoscope (Flexible Or Rigid)
- ERAOtoscope
- HLXPhotostimulator, Ac-Powered
- FHOPneumoperitoneum Needle
- GEXPowered Laser Surgical Instrument
- GADRetractor
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain