# K962693: Montgomery Radiopaque Laryngeal Keel

- Pathway: 510(k) (Traditional)
- Applicant: Boston Medical Products, Inc.
- Decided: Aug 9, 1996 after 29 days
- Product code: FWN (Prosthesis, Larynx (Stents And Keels))
- 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) Montgomery Laryngeal Keel: named in the summary without a submission number

## Indications for use
1. To repair simple anterior glottic stenosis due to anterior commissure web formation. 2. To prevent anterior glottic stenosis in situations where anterior commissure stenosis is fikely to occur (eg, following extralaryngeal or endolaryngeal trauma with loss of anterior commissure). 3. To prevent the anterior glotlic stenosis immediately following removal of the Monigomery Laryngeal Stent.

Source page: https://510kreport.com/device/K962693
Methodology: https://510kreport.com/methodology