FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP
K Number: K950632
·
Decision May 12, 1995
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
12
Review Days
88
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INNERDYNE STEP TROCAR EXPANDABLE PORT, STEP
- K Number
- K950632
- 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
- February 13, 1995
- Decision Date
- May 12, 1995
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCJ), ordered by most recent decision date.
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)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Tech-Image Video Endoscope System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TroKit Laparoscope Lens Wiper
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Inno-Port Disposable Bladed Trocar
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
4K NIR/ICG Imaging System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MediBot Needle Driver Uno
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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 |
| 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 |