FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP
K Number: K970754
·
Decision Apr 21, 1997
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
12
Review Days
49
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Basic Information
- Device Name
- INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP
- K Number
- K970754
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innerdyne, Inc.
- Date Received
- March 3, 1997
- Decision Date
- April 21, 1997
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | 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 |
| K990854 | INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE | Aug 2, 1999 | 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 |
| 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 |