QUIKCLOT HEMOSTATIC DRESSING— 510(k) K123387
Substantially EquivalentZ-Medica, LLC
FDA 510(k) clearance K123387 for QUIKCLOT HEMOSTATIC DRESSING, Substantially Equivalent on 2013-04-12. Applicant: Z-Medica, LLC. Device class: Unclassified.
Clearance details
- Applicant
- Z-Medica, LLC
- Product code
- Product code QSY
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wallingford, CT, US
Recent devices under product code QSY
view allMore clearances from Z-Medica, LLC
view allAdverse 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 K123387
K-number listed on FDA's recall record- Z-0925-2018 — QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries
- Z-2612-2017 — QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For use as a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of severely bleeding wounds such as surgical wounds (operative, postoperative, dermatological, etc.) and traumatic injuries
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123387.
Data sourced from openFDA. This site is unofficial and independent of the FDA.