# K974653: Silicone Elastomer Sheeting

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Surgical Products, Inc.
- Decided: Mar 13, 1998 after 88 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K033796: Kurz Silicone Strips, Models SF-1, SF-1W, SF-1 BS (2004), 1 descendant of its own
- K260266: Tympendi™ (810) (2026), 0 descendants of its own

## Indications for use
Specialty Surgical Products Silicone Sheeting is intended for a variety of medical purposes both in short term and long term applications. For short term application the indications for usc are: for nasal splinting, wound dressings, managment of hypertrophic or keloid scarring, to prevent soft tissue-fibrosis or bony ankylosis following surgical correction of trismus, temporary joint spacers and laboratory uses. For long-term application the indications for use are: for nasal septal repair, orbital floor reconstruction, tympanic membrane repair, dialysis shunt anchoring, duramater repair, staged repair of omphalocele, for lengthening extraocular muscles in select cases of strabismus, as a protective sheathing to help facilitate neural regeneration and tendon anastomosis, as a protective sheathing to help facilitate osteogenesis, guided tissue regeneration between teeth and gingival margin, or external ear canal for example Warning: Not for permanent use in Temporo Mandibular Joint applications.

Source page: https://510kreport.com/device/K974653
Methodology: https://510kreport.com/methodology