FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
CLARUS CHOLANGIOGRAM CATHETER KIT
K Number: K925742
·
Decision Jun 1, 1993
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
23
Applicant Total
22
Review Days
200
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Basic Information
- Device Name
- CLARUS CHOLANGIOGRAM CATHETER KIT
- K Number
- K925742
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Clarus Medical Systems, Inc.
- Date Received
- November 13, 1992
- Decision Date
- June 1, 1993
- Product Code
- GBZ
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GBZ | Catheter, Cholangiography | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBZ), ordered by most recent decision date.
PRE-VIEW CHOLANGIOGRAPHY CLAMP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ENDOPATH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
STRYKER ENDOSCOPY CHOLANGIOGRAM KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |