SUNTOUCH TOPICAL HEMOSTATIC DRESSING— 510(k) K112800
Substantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.
FDA 510(k) clearance K112800 for SUNTOUCH TOPICAL HEMOSTATIC DRESSING, Substantially Equivalent on 2012-05-23. Applicant: Huizhou Foryou Medical Devices Co., Ltd.. Device class: Unclassified.
Clearance details
- Applicant
- Huizhou Foryou Medical Devices Co., Ltd.
- Product code
- Code QSY
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pennington, NJ, US
Recent devices under product code QSY
view allMore clearances from Huizhou Foryou Medical Devices Co., Ltd.
view all- K254256 — LUOFUCON® Wound Matrix
- K250642 — LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
- K240809 — LUOFUCON® Silver Collagen Dressing
- K242856 — LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)
- K240485 — LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)
Adverse events under product code QSY
product code QSY- Death
- 5
- Other
- 1
- Total
- 6
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 K112800
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K112800.
Data sourced from openFDA. This site is unofficial and independent of the FDA.