# K973578: Invotec Ear Tampon (Wick) W/String

- Pathway: 510(k) (Traditional)
- Applicant: Invotec International, Inc.
- Decided: Nov 6, 1997 after 48 days
- Product code: KCN (Ear Wick)
- Device class: 1
- Regulation: 21 CFR 874.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K070715: Nasopore Ear (2007), 1 descendant of its own
- K210411: PosiSep EAR Fragmentable Ear Dressing (2022), 0 descendants of its own
- K062540: Nasopore Ear, Models  ND04, ND05 (2006), 0 descendants of its own

## Indications for use
The Invotec Ear Tampon (wick) w/ string, is indicated for use as a ear packing for use after internal ear surgery. The packing is to be used in the ear canal as a surgical packing.

Source page: https://510kreport.com/device/K973578
Methodology: https://510kreport.com/methodology