FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OCTOTMPORT
K Number: K112196
·
Decision Sep 14, 2011
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
10
Applicant Total
2
Review Days
44
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
- OCTOTMPORT
- K Number
- K112196
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dalim Surgnet Corporation
- Date Received
- August 1, 2011
- Decision Date
- September 14, 2011
- 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.
Uni-port
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CORE-SPORT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
AFS Medical Sterile Single-Use Access Port System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FMX314 Surgical Platform
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Endo Keeper
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ASC QUADPORT + LAPAROSCOPIC ACCESS DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Dalim Surgnet Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K100045 | OCTO | Jun 25, 2010 | Substantially Equivalent |