FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Instinct Plus Endoscopic Clipping Device
K Number: K192697
·
Decision Mar 5, 2020
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
62
Applicant Total
4
Review Days
161
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Basic Information
- Device Name
- Instinct Plus Endoscopic Clipping Device
- K Number
- K192697
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4400
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Endoscopy
- Date Received
- September 26, 2019
- Decision Date
- March 5, 2020
- Product Code
- PKL
- 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 |
|---|---|---|---|
| PKL | Hemostatic Metal Clip For The Gi Tract | FDA class 2 | Gastroenterology, Urology |
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Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)
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