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510(k) DEN160012

D2 Dressing by Z-Medica, LLC — Product Code POD

DEN160012 is an FDA 510(k) premarket notification submitted by Z-Medica, LLC for the device "D2 Dressing". The FDA issued a decision of De Novo Granted on June 30, 2017. 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
DENG (De Novo Granted)
Decision Date
June 30, 2017
Date Received
March 16, 2016
Clearance Type
Direct
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)
  • K200167 — QuikClot Control+ (April 23, 2020)
  • K181641 — QuikClot Radial (December 24, 2018)
  • 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)
  • K200167 — QuikClot Control+ (April 23, 2020)
  • K183190 — NuStat (September 25, 2019)

FDA data resources