Hemospray Endoscopic Hemostat— 510(k) K200972
Substantially EquivalentWilson-Cook Medical, Inc.
FDA 510(k) clearance K200972 for Hemospray Endoscopic Hemostat, Substantially Equivalent on 2020-06-10. Applicant: Wilson-Cook Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Wilson-Cook Medical, Inc.
- Product code
- Code QAU
- Device class
- Class 2
- Regulation
- 21 CFR 878.4456
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Winston-Salem, NC, US
Recent devices under product code QAU
view allMore clearances from Wilson-Cook Medical, Inc.
view allAdverse events under product code QAU
product code QAU- Death
- 6
- Injury
- 135
- Malfunction
- 621
- Total
- 762
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K200972
K-number listed on FDA's recall record- Z-0036-2025 — Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.
- Z-1978-2023 — Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;
- Z-1979-2023 — Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200972.
Data sourced from openFDA. This site is unofficial and independent of the FDA.