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510(k) K200167

QuikClot Control+ by Z-Medica, LLC — Product Code POD

K200167 is an FDA 510(k) premarket notification submitted by Z-Medica, LLC for the device "QuikClot Control+". The FDA issued a decision of Substantially Equivalent on April 23, 2020. The device falls under product code POD (Temporary, Internal Use Hemostatic), a Class II device regulated under 21 CFR 878.4454. Z-Medica, LLC has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 2020
Date Received
January 23, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Temporary, Internal Use Hemostatic
Device Class
Class II
Regulation Number
878.4454
Review Panel
SU
Submission Type

Intended to control severely bleeding wounds

Other clearances by Z-Medica, LLC

  • K220971 — QuikClot Control+ Hemostatic Dressing (December 14, 2022)
  • K181641 — QuikClot Radial (December 24, 2018)
  • DEN160012 — D2 Dressing (June 30, 2017)
  • K140757 — D2 HEMOSTANTIC DRESSING (July 17, 2014)
  • K123387 — QUIKCLOT HEMOSTATIC DRESSING (April 12, 2013)

Other clearances for product code POD

  • K243553 — QuikClot Control+ Hemostatic Device (March 18, 2025)
  • K213198 — Ax-Surgi Surgical Hemostat (January 5, 2023)
  • K220971 — QuikClot Control+ Hemostatic Dressing (December 14, 2022)
  • K183190 — NuStat (September 25, 2019)
  • DEN160012 — D2 Dressing (June 30, 2017)

FDA data resources