# K040042: Medisil Silicone Sheeting

- Pathway: 510(k) (Traditional)
- Applicant: Medisil Corporation
- Decided: Apr 1, 2004 after 80 days
- Product code: MIB (Elastomer, Silicone Block)
- 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 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
- K162624: Pre-Formed Penile Silicone Block (2017), 4 descendants of its own
- K181387: Pre-Formed Penile Silicone Block (2019), 3 descendants of its own
- K220760: Pre-Formed Penile Silicone Block (2022), 1 descendant of its own
- K223051: Pre-Formed Silicone Block (2023), 0 descendants of its own
- K200073: AugMENTA Penile Implant (2022), 0 descendants of its own

## Indications for use
Sheeting is indicated for short term use for nasal splinting, wound dressings, scar coverings and temporary joint spacers. For long term use, this device is indicated for tympanic membrane repair, dural covering, nasal septal repair, tendon anastamosis and neural repair, correction of strabismus, galea repair, orbital floor repair, hemodialysis shunt anchors, facilitation of osteogenesis, repair of urethral strictures, staged repair of omphalocoel and repair of orbital floor fractures.

Source page: https://510kreport.com/device/K040042
Methodology: https://510kreport.com/methodology