FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LAPAROSCOPIC BALLOON RETRACTOR
K Number: K926480
·
Decision Oct 15, 1993
Classifications
1
FEI Numbers
573
Registration Numbers
573
Same Product Code
1391
Applicant Total
50
Review Days
290
Basic Information
- Device Name
- LAPAROSCOPIC BALLOON RETRACTOR
- K Number
- K926480
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- ORIGIN MEDSYSTEMS, INC.
- Date Received
- December 29, 1992
- Decision Date
- October 15, 1993
- 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 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 |