FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES]
K Number: K960936
·
Decision Jul 24, 1996
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
337
Applicant Total
50
Review Days
138
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
- RESPOSABLE TROCAR SYSTEM [5MM, 5MM SHORT, 10MM AND 12MM SIZES]
- K Number
- K960936
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1720
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Origin Medsystems, Inc.
- Date Received
- March 8, 1996
- Decision Date
- July 24, 1996
- Product Code
- HET
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HET | Laparoscope, Gynecologic (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HET), ordered by most recent decision date.
SIRIUS Endoscope System (PR-SI-1230)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
i-Cut
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SIRIUS Endoscope System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Video Endoscopy System, 3D Video Endoscopy System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SurroundScope System
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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 |
| K960637 | 5MM ENDOSCOPE | Jun 14, 1996 | Substantially Equivalent |
| K955163 | DISSECTION PROBE | Jan 24, 1996 | Substantially Equivalent |