FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long
K Number: K190621
·
Decision Apr 23, 2019
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
187
Applicant Total
4
Review Days
43
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Basic Information
- Device Name
- SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long
- K Number
- K190621
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4300
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sumitomo Bakelite Co., Ltd.
- Date Received
- March 11, 2019
- Decision Date
- April 23, 2019
- Product Code
- KNS
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Sumitomo Bakelite Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K182520 | Flexible Overtube | May 15, 2019 | Substantially Equivalent |
| K173004 | SB Soft Hood - Straight type, SB Soft Hood - Undercut type | May 8, 2018 | Substantially Equivalent |
| K152771 | SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long | Jun 17, 2016 | Substantially Equivalent |