FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Hemospray Endoscopic Hemostat
K Number: K200972
·
Decision Jun 10, 2020
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
10
Applicant Total
125
Review Days
58
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Basic Information
- Device Name
- Hemospray Endoscopic Hemostat
- K Number
- K200972
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4456
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wilson-Cook Medical, Inc.
- Date Received
- April 13, 2020
- Decision Date
- June 10, 2020
- Product Code
- QAU
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| QAU | Hemostatic Device For Endoscopic Gastrointestinal Use | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QAU), ordered by most recent decision date.
Hemospray Endoscopic Hemostat (HEMO-[X])
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Resolv Endoscopic Hemostat System
FDA 510(k)
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FDA 510(k)
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·General, Plastic Surgery
Other Clearances by Wilson-Cook Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253302 | Hemospray Endoscopic Hemostat (HEMO-[X]) | Jun 2, 2026 | Substantially Equivalent |
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | Jan 17, 2025 | Substantially Equivalent |
| K213356 | Entuit PEG, Entuit PEGJ | Jan 20, 2022 | Unknown |
| K212323 | Instinct Plus Endoscopic Clipping Device | Aug 25, 2021 | Substantially Equivalent |
| K201322 | Entuit Nasal Jejunal Feeding Tube | Jun 17, 2020 | Unknown |
| K200247 | Fusion Quattro Extraction Balloon | Feb 27, 2020 | Substantially Equivalent |
| K192339 | TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord | Jan 30, 2020 | Substantially Equivalent |
| K193344 | Tri-Ex Extraction Balloon with Multiple Sizing | Dec 13, 2019 | Substantially Equivalent |
| K192908 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes | Nov 14, 2019 | Substantially Equivalent |
| K191048 | AcuSnare Polypectomy Snare - Duckbill | Jul 18, 2019 | Substantially Equivalent |