# K964484: Kartush TM Patcher

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: Jan 24, 1997 after 78 days
- Product code: KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material))
- Device class: 2
- Regulation: 21 CFR 874.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) silicone sheeting: named in the summary without a submission number
- (no number) tympanostomy tube: named in the summary without a submission number
- (no number) nasal septal button: named in the summary without a submission number

## Indications for use
Kartush TM Patcher is intended for use as a patch to aid coverage of a tympanic membrane perforation in a dry ear.

Source page: https://510kreport.com/device/K964484
Methodology: https://510kreport.com/methodology