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510(k) K000108

RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100 by Bhk Holding — Product Code EMX

K000108 is an FDA 510(k) premarket notification submitted by Bhk Holding for the device "RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100". The FDA issued a decision of Substantially Equivalent on May 23, 2000. The device falls under product code EMX (Balloon, Epistaxis), a Class I device regulated under 21 CFR 874.4100.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2000
Date Received
January 14, 2000
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

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  • 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