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510(k) K973578

INVOTEC EAR TAMPON (WICK) W/STRING by Invotec International, Inc. — Product Code KCN

K973578 is an FDA 510(k) premarket notification submitted by Invotec International, Inc. for the device "INVOTEC EAR TAMPON (WICK) W/STRING". The FDA issued a decision of Substantially Equivalent on November 6, 1997. The device falls under product code KCN (Ear Wick), a Class I device regulated under 21 CFR 874.5220. Invotec International, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1997
Date Received
September 19, 1997
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 Invotec International, Inc.

  • K122040 — INVOTEC LARYNGEAL ELECTRODE (October 31, 2013)
  • K080740 — CLEARVIEW ENDOSCOPE COVER (December 31, 2008)
  • K030492 — TITANIUM OSSICULAR REPLACMENT SYSTEM (March 3, 2003)
  • K973580 — INVOTEC CLEAN PAD (December 10, 1997)
  • K971000 — EPISTAXIS NASAL PACK (May 14, 1997)
  • K930114 — TRACHEOSTOMY T-TUBE (March 19, 1993)
  • K911041 — INVOTEC X-RAY CASSETTE EQUIPMENT DRAPE (June 4, 1991)
  • K911040 — INVOTEC MICROSCOPE DRAPE (June 3, 1991)
  • K911039 — INVOTEC EAR DRAPE (May 13, 1991)
  • K901923 — INVOTEC POLY-MESH MANDIBULAR TRAY (October 31, 1990)

Other clearances for product code KCN

  • K062540 — NASOPORE EAR, MODELS ND04, ND05 (October 18, 2006)
  • K920357 — ULTRACELL EAR WICK (February 1, 1993)
  • K791059 — POPE OTO-WICK, STERILE & NON-STERILE (July 17, 1979)

FDA data resources