FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT
K Number: K914755
·
Decision Mar 30, 1992
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
25
Applicant Total
50
Review Days
160
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Basic Information
- Device Name
- DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT
- K Number
- K914755
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Davol, Inc.
- Date Received
- October 22, 1991
- Decision Date
- March 30, 1992
- Product Code
- GCA
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCA), ordered by most recent decision date.
Disposable Stone Retrieval Balloon Catheter
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FDA Class 2
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Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C)
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FDA Class 2
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SpyGlass Discover Balloon Dilation Catheter
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FDA Class 2
·Gastroenterology, Urology
Stone Retrieval Balloon Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Stone Retrieval Balloon
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FDA Class 2
·Gastroenterology, Urology
Fusion Quattro Extraction Balloon
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Davol, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251557 | Bard® Mesh; Bard® Mesh Pre-Shaped | Jun 12, 2025 | Substantially Equivalent |
| K250098 | Bard Soft Mesh; Bard Soft Mesh Pre-Shaped | Apr 9, 2025 | Substantially Equivalent |
| K031213 | AQUASENS FLUID MONITORING SYSTEM | Apr 30, 2003 | Substantially Equivalent |
| K030307 | DAVOL ARTHROVENT OUTFLOW TUBING | Feb 13, 2003 | Substantially Equivalent |
| K003323 | COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 | Jan 22, 2001 | Substantially Equivalent |
| K003790 | DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005 | Dec 22, 2000 | Substantially Equivalent |
| K931899 | DAVOL ATS | Nov 15, 1994 | Substantially Equivalent |
| K941334 | DAVOL LAPAROSCOPIC SUCTION IRRIGATION PROBE | Jun 14, 1994 | Substantially Equivalent |
| K921405 | DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIP | Mar 25, 1994 | Substantially Equivalent |
| K935503 | DAVOL LAPAROSCOPIC INSUFFLATION TUBING SET | Mar 7, 1994 | Substantially Equivalent |