FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRIPORT, TRIPORT+, TRIPORT15, QUADPORT
K Number: K111407
·
Decision Jan 18, 2012
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
10
Applicant Total
9
Review Days
244
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Basic Information
- Device Name
- TRIPORT, TRIPORT+, TRIPORT15, QUADPORT
- K Number
- K111407
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Advanced Surgical Concepts
- Date Received
- May 19, 2011
- Decision Date
- January 18, 2012
- Product Code
- OTJ
- 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 |
|---|---|---|---|
| OTJ | Laparoscopic Single Port Access Device | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OTJ), ordered by most recent decision date.
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ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE
FDA 510(k)
FDA Class 2
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Other Clearances by Advanced Surgical Concepts
| K Number | Device Name | ||
|---|---|---|---|
| K232701 | Guardenia (GAR-1) | Sep 29, 2023 | Substantially Equivalent |
| K192898 | PneumoLiner | Feb 25, 2020 | Substantially Equivalent |
| K121309 | ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE | Sep 6, 2012 | Substantially Equivalent |
| K110004 | ASC TRIPORT+ LAPAROSCOPIC ACCESS DEVICE | Jan 26, 2011 | Substantially Equivalent |
| K101794 | ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA | Nov 29, 2010 | Substantially Equivalent |
| K073719 | ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE | Jan 29, 2008 | Substantially Equivalent |
| K073170 | R-PORT II LAPAROSCOPIC ACCESS DEVICE | Dec 3, 2007 | Substantially Equivalent |
| K070158 | R-PORT LAPAROSCOPIC ACCESS DEVICE | Aug 23, 2007 | Substantially Equivalent |