FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA
K Number: K946002
·
Decision Jan 5, 1995
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
50
Review Days
44
Basic Information
- Device Name
- ORIGIN PREPERITONEAL DISSECTION BALLOON SYSTEM (PDBS)--EXTRA
- K Number
- K946002
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ORIGIN MEDSYSTEMS, INC.
- Date Received
- November 22, 1994
- Decision Date
- January 5, 1995
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by ORIGIN MEDSYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K992353 | BLUNT TIP TROCAR PORT | Jul 30, 1999 | Substantially Equivalent |
| K981700 | VASOVIEW DISSECTION/VESSEL HARVESTING SYSTEM | May 29, 1998 | Substantially Equivalent |
| K972685 | ORIGIN LIGATOR DEVICE | Oct 1, 1997 | Substantially Equivalent |
| K970611 | ORIGIN CARDIAC STABLIZER OCCLUDER | Aug 19, 1997 | Substantially Equivalent |
| K965121 | CANNULA | Mar 20, 1997 | Substantially Equivalent |
| K964171 | VASOVIEW BALLOON DISSECTION SYSTEM | Feb 14, 1997 | Substantially Equivalent |
| K962104 | AIRLIFT BALLOON RETRACTON SYSTEM | Sep 11, 1996 | Substantially Equivalent |
| K962005 | EXTRAHAND BALLOON RETRACTOR | Aug 12, 1996 | Substantially Equivalent |
| K960936 | RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES] | Jul 24, 1996 | Substantially Equivalent |
| K960637 | 5MM ENDOSCOPE | Jun 14, 1996 | Substantially Equivalent |