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510(k) K935724

THE EXPANDACELL SINUS PACK by Denver Splint Co. — Product Code EMX

K935724 is an FDA 510(k) premarket notification submitted by Denver Splint Co. for the device "THE EXPANDACELL SINUS PACK". The FDA issued a decision of Substantially Equivalent on May 12, 1994. The device falls under product code EMX (Balloon, Epistaxis), a Class I device regulated under 21 CFR 874.4100. Denver Splint Co. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1994
Date Received
December 1, 1993
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 Denver Splint Co.

  • K940798 — SHIPPERT PRESSURE BANDAGE (September 28, 1994)
  • K940133 — THE EXPANDACELL EAR PACK (May 23, 1994)
  • K922062 — THE DENVER CAUTERY (January 12, 1993)

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)
  • 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)

FDA data resources