FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Laparoscope Lens Shield Device (LENS)
K Number: K170103
·
Decision Feb 16, 2017
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
7
Review Days
35
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Basic Information
- Device Name
- Laparoscope Lens Shield Device (LENS)
- K Number
- K170103
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medeon Biodesign, Inc.
- Date Received
- January 12, 2017
- Decision Date
- February 16, 2017
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GCJ), ordered by most recent decision date.
FloShield Air System (FSS-01-1000T - 10mm, 0 Degree FloShield Air, FSS-02-1030T - 10mm, 30 Degree FloShield Air, FSS-03-1045T - 10mm, 45 Degree FloShield Air, FSS-01-0500T - 5mm, 0 Degree FloShield Air, FSS-02-0530T - 5mm, 30 Degree FloShield Air, FSS-01-0545T - 5mm, 45 Degree FloShield Air)
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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 |
| K160117 | AbClose - Port Site Closure Device | Sep 9, 2016 | Substantially Equivalent |
| K160172 | Laparoscope Lens Shield Device | Apr 21, 2016 | Substantially Equivalent |
| K151117 | Laparoscope Lens Shield Device | Aug 20, 2015 | Substantially Equivalent |