FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MENLO CARE AQUASTENT SET
K Number: K923394
·
Decision Nov 16, 1993
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
121
Applicant Total
31
Review Days
494
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Basic Information
- Device Name
- MENLO CARE AQUASTENT SET
- K Number
- K923394
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4620
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Menlo Care, Inc.
- Date Received
- July 10, 1992
- Decision Date
- November 16, 1993
- Product Code
- FAD
- 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 |
|---|---|---|---|
| FAD | Stent, Ureteral | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FAD), ordered by most recent decision date.
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Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set
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RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
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Other Clearances by Menlo Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K964447 | PICC CATHETER/MIDLINE CATHETER | Apr 16, 1997 | Substantially Equivalent |
| K951620 | MIDMARK MIDLINE CATHETER | Apr 4, 1996 | Substantially Equivalent |
| K945521 | CENTERMARK(R) PICC INSERTION TRAY LANDMARK(R) MIDLINE CATHETER PREP TRAY | Apr 6, 1995 | Substantially Equivalent |
| K944968 | LANDMARK MIDLINE CATHETER | Mar 29, 1995 | Substantially Equivalent |
| K950737 | LANDMARK MIDLINE CATHETER | Mar 29, 1995 | Substantially Equivalent |
| K943893 | PERCUTANEOUS GRAINAGE CATHETER | Mar 7, 1995 | Substantially Equivalent |
| K943143 | BILIARY STENT | Feb 28, 1995 | Substantially Equivalent |
| K930048 | SAFE-PICC CATHETER | May 12, 1994 | Substantially Equivalent |
| K933941 | MENLO CARE URINARY DIVERSION STENT | Mar 31, 1994 | Substantially Equivalent |
| K940127 | CENTERMARK SECURING WINGS | Feb 9, 1994 | Substantially Equivalent |