FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
AbClose - Port Site Closure Device
K Number: K160117
·
Decision Sep 9, 2016
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
69
Applicant Total
7
Review Days
234
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Basic Information
- Device Name
- AbClose - Port Site Closure Device
- K Number
- K160117
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medeon Biodesign, Inc.
- Date Received
- January 19, 2016
- Decision Date
- September 9, 2016
- Product Code
- OCW
- 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 |
|---|---|---|---|
| OCW | Endoscopic Tissue Approximation Device | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Medeon Biodesign, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K200902 | ClickClean | Apr 30, 2020 | Substantially Equivalent |
| K193652 | AbClose - Port Site Closure Device | Mar 26, 2020 | Substantially Equivalent |
| K192891 | Laparoscope Lens Shield Device (LENS) | Nov 7, 2019 | Substantially Equivalent |
| K170103 | Laparoscope Lens Shield Device (LENS) | Feb 16, 2017 | Substantially Equivalent |
| K160172 | Laparoscope Lens Shield Device | Apr 21, 2016 | Substantially Equivalent |
| K151117 | Laparoscope Lens Shield Device | Aug 20, 2015 | Substantially Equivalent |