# K964534: Otosilk Otological Graft Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Boston Medical Products, Inc.
- Decided: Apr 9, 1997 after 148 days
- Product code: NAD (Dressing, Wound, Occlusive)
- Device class: 1
- Regulation: 21 CFR 878.4020
- 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) Product No. XO-2904, subsequently marketed as Product No. 14-28010: named in the summary without a submission number

## Indications for use
To be used as a temporary dressing in the external auditory canal following tympanoplasty or stapedectomy procedures.

Source page: https://510kreport.com/device/K964534
Methodology: https://510kreport.com/methodology