FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE
K Number: K990854
·
Decision Aug 2, 1999
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
12
Review Days
140
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Basic Information
- Device Name
- INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE
- K Number
- K990854
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innerdyne, Inc.
- Date Received
- March 15, 1999
- Decision Date
- August 2, 1999
- Product Code
- FGE
- 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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Innerdyne, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992668 | INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS) | May 26, 2000 | Substantially Equivalent |
| K990493 | INNERDYNE GENERIC RADIALLY EXPANDING DILATION, G-RED DEVICE | May 18, 1999 | Substantially Equivalent |
| K982417 | INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP | Oct 7, 1998 | Substantially Equivalent |
| K980578 | INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED) | Sep 11, 1998 | Substantially Equivalent |
| K972684 | INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM | Oct 10, 1997 | Substantially Equivalent |
| K971230 | SHERWOOD MEDICAL COMPANY , KANGAROO, ENTRISTAR, PERCUTANEOUS GASTROSTOMY KIT | Jun 13, 1997 | Substantially Equivalent |
| K970754 | INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP | Apr 21, 1997 | Substantially Equivalent |
| K961940 | INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP | Jul 10, 1996 | Substantially Equivalent |
| K961430 | INNERDYNE STEP TROCAR EXPANDABLE PORT, MINISTEP | May 28, 1996 | Substantially Equivalent |
| K950632 | INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP | May 12, 1995 | Substantially Equivalent |