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510(k) K920357

ULTRACELL EAR WICK by Ultracell Medical Technologies, Inc. — Product Code KCN

K920357 is an FDA 510(k) premarket notification submitted by Ultracell Medical Technologies, Inc. for the device "ULTRACELL EAR WICK". The FDA issued a decision of Substantially Equivalent on February 1, 1993. The device falls under product code KCN (Ear Wick), a Class I device regulated under 21 CFR 874.5220. Ultracell Medical Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 1993
Date Received
January 27, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ear Wick
Device Class
Class I
Regulation Number
874.5220
Review Panel
EN
Submission Type

Other clearances by Ultracell Medical Technologies, Inc.

  • K012196 — ULTRACELL ABSORBENT STICK (August 24, 2001)
  • K972633 — ULTRACELL SUCTION SPONGE (December 17, 1997)
  • K972634 — ULTRACELL SUCTION SPONGE (December 17, 1997)
  • K973083 — ULTRACELL NEURO SPONGES (December 9, 1997)
  • K973558 — VISUAL ENDOSCOPIC NON-ALCOHOL ULTRACELL SPONGE (VENUS) (November 24, 1997)
  • K973085 — ULTRACELL PACKING WITH SLEEVE (November 18, 1997)
  • K972635 — ULTRACELL SUCTION SPONGE (October 1, 1997)
  • K970328 — ULTRACELL NEURO SPONGES (April 21, 1997)
  • K950647 — ULTRACELL NEURO SPONGES (August 15, 1995)
  • K950373 — ULTRACELL ORTHOPEDIC SPONGES (April 17, 1995)

Other clearances for product code KCN

  • K062540 — NASOPORE EAR, MODELS ND04, ND05 (October 18, 2006)
  • K973578 — INVOTEC EAR TAMPON (WICK) W/STRING (November 6, 1997)
  • K791059 — POPE OTO-WICK, STERILE & NON-STERILE (July 17, 1979)

FDA data resources