Home / 510(k) Clearances / K971411

510(k) K971411

DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K by Bentec Medical, Inc. — Product Code EMX

K971411 is an FDA 510(k) premarket notification submitted by Bentec Medical, Inc. for the device "DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K". The FDA issued a decision of Substantially Equivalent on June 3, 1997. The device falls under product code EMX (Balloon, Epistaxis), a Class I device regulated under 21 CFR 874.4100. Bentec Medical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1997
Date Received
April 16, 1997
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 Bentec Medical, Inc.

  • K002650 — VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726 (February 16, 2001)
  • K971517 — SILICONE PUTTY EAR PLUGS (June 2, 1997)

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