FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CLARUS ENDOSCOPIC BALL PROBE
K Number: K926048
·
Decision Apr 7, 1993
Classifications
1
FEI Numbers
136
Registration Numbers
136
Same Product Code
12
Applicant Total
22
Review Days
127
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CLARUS ENDOSCOPIC BALL PROBE
- K Number
- K926048
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 882.4525
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clarus Medical Systems, Inc.
- Date Received
- December 1, 1992
- Decision Date
- April 7, 1993
- Product Code
- GZX
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GZX | Instrument, Microsurgical | FDA class 1 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GZX), ordered by most recent decision date.
MICROSURGICAL INSTRUMENTS
FDA 510(k)
FDA Class 1
·Neurology
J105 JAMES SURGICAL SYSTEM I/A PACK
FDA 510(k)
FDA Class 1
·Neurology
MICROSURGICAL KERATOME
FDA 510(k)
FDA Class 1
·Neurology
RANGE OF NEUROSURGICAL INSTRUMENTS IN TITANIUM
FDA 510(k)
FDA Class 1
·Neurology
RANGE OF CROCODILE ACTION INSTRUMENTS
FDA 510(k)
FDA Class 1
·Neurology
MICRA MICROSURGICAL INSTRUMENTS
FDA 510(k)
FDA Class 1
·Neurology
Other Clearances by Clarus Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K980588 | CLARUS ENDOSCOPIC DISCECTOMY SYSTEM SITETRAC MODEL 6000 | Aug 18, 1998 | Substantially Equivalent |
| K974579 | PERCSCOPE MODEL 2600 | Feb 18, 1998 | Substantially Equivalent |
| K971584 | CLARUS MODEL 2127-900 SERIES ENDOSCOPE ADATER (2127-900 SERIES) | May 23, 1997 | Substantially Equivalent |
| K971455 | CLARUS MODEL 5197 SIGHTLITE | May 20, 1997 | Substantially Equivalent |
| K960915 | CLARUS NEUROPEN ENDOSCOPIC PLACEMENT KIT MODEL 2125-XXX | Dec 24, 1996 | Substantially Equivalent |
| K962255 | CLARUS MURPHYPEN ENDOSCOPE(2127-XXX) | Sep 11, 1996 | Substantially Equivalent |
| K955598 | CLARUS SPINEPEN MODEL 2126 | Feb 6, 1996 | Substantially Equivalent |
| K953685 | INSTRUMENT SCOPE | Oct 12, 1995 | Substantially Equivalent |
| K945633 | NEURO CHANNEL ENDOSCOPE MODEL 2232 | Sep 19, 1995 | Substantially Equivalent |
| K945296 | CLARUS PHOENIX NEURO ENDOSCOPE MODEL 2160 | Jul 14, 1995 | Substantially Equivalent |