FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005
K Number: K003790
·
Decision Dec 22, 2000
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
50
Review Days
14
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Basic Information
- Device Name
- DAVOL X-STREAM LAPAROSCOPIC IRRIGATION SYSTEM, MODELS 5551000, 5552000, 5552001, 552002, 5552003, 5552004, 5552005
- K Number
- K003790
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Davol, Inc.
- Date Received
- December 8, 2000
- Decision Date
- December 22, 2000
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
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FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
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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 |
| 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 |
| K926479 | BARD LAPAROSCOPIC IRRIGATOR PUMP SYSTEM | Mar 1, 1994 | Substantially Equivalent |