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510(k) K983276

HYDROFERA BACTERISTATIC NASAL DRESSING by Hydrofera, LLC — Product Code EMX

K983276 is an FDA 510(k) premarket notification submitted by Hydrofera, LLC for the device "HYDROFERA BACTERISTATIC NASAL DRESSING". The FDA issued a decision of Substantially Equivalent on September 14, 1999. The device falls under product code EMX (Balloon, Epistaxis), a Class I device regulated under 21 CFR 874.4100. Hydrofera, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1999
Date Received
September 17, 1998
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 Hydrofera, LLC

  • K190268 — Hydrofera Blue READY - Border (November 6, 2019)
  • K130670 — HYDROFERA BLUE PU BACTERIOSTATIC DRESSING (January 2, 2014)
  • K023138 — HYDROFERA BACTERIOSTATIC WOUND DRESSING (January 17, 2003)
  • K013462 — HYDROFERA BACTERIOSTATIC WOUND DRESSING (January 11, 2002)
  • K974313 — HYDROFERA SURGICAL SPEAR (March 2, 1998)
  • K974316 — HYDROFERA FEMORAL WICK (February 13, 1998)

Other clearances for product code EMX

  • K220326 — PosiSep X BAM Hemostat Dressing/Intranasal Splint (November 14, 2022)
  • 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)
  • 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