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510(k) K220326

PosiSep X BAM Hemostat Dressing/Intranasal Splint by Hemostasis, LLC — Product Code EMX

K220326 is an FDA 510(k) premarket notification submitted by Hemostasis, LLC for the device "PosiSep X BAM Hemostat Dressing/Intranasal Splint". The FDA issued a decision of Substantially Equivalent on November 14, 2022. The device falls under product code EMX (Balloon, Epistaxis), a Class I device regulated under 21 CFR 874.4100. Hemostasis, LLC has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2022
Date Received
February 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Balloon, Epistaxis
Device Class
Class I
Regulation Number
874.4100
Review Panel
EN
Submission Type

Other clearances by Hemostasis, LLC

  • K234131 — Resolv Endoscopic Hemostat System (July 26, 2024)
  • K210411 — PosiSep EAR Fragmentable Ear Dressing (May 5, 2022)
  • K142348 — OsteoSeal Bone Hemostat (January 23, 2015)
  • K122494 — POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT (March 27, 2013)
  • K122886 — NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING (November 15, 2012)
  • K120958 — POSISEP AND POSISEP X HEMOSTAT DRESSINGS (July 25, 2012)
  • K102459 — NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE (December 3, 2010)
  • K072900 — EXCELARREST FOAM (October 26, 2007)
  • K070211 — TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM (April 5, 2007)

Other clearances for product code EMX

  • K041446 — NASALCEASE (July 1, 2004)
  • K000108 — RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR- (May 23, 2000)
  • K993362 — HYLASINE (March 13, 2000)
  • K983276 — HYDROFERA BACTERISTATIC NASAL DRESSING (September 14, 1999)
  • K982731 — MEROGEL NASAL DRESSING AND SINUS STENT (February 2, 1999)
  • K984069 — ENTAXIS NASAL PACKING (January 25, 1999)
  • K981966 — NOSEBLEED NOSECLIP (August 14, 1998)
  • K973656 — DISPOSABLE SILICONE EPISTAXIS CATHETER (November 18, 1997)
  • K973085 — ULTRACELL PACKING WITH SLEEVE (November 18, 1997)
  • K972922 — VYKER SILICONE EPISTAXIS CATHETER V-27030, VYKER SILICONE EPISTAXIS CATHETER KIT (October 8, 1997)

FDA data resources