# K973730: Durasil I and Durasil II

- Pathway: 510(k) (Traditional)
- Applicant: Hanson Medical, Inc.
- Decided: Dec 24, 1997 after 85 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
Longest line of descent: 1 generation back to K971480 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971480: Duralastic I and Duralastic II, Allied Biomedical Corp. (1997) Summary page 1.

## Indications for use
Durasil I (Short Term) nasal splinting, wound dressings, wound drains, covering for gastroschisis, suture bolsters, scar coverings, laboratory uses, temporary facilitation of osteogenesis, and guided tissue regeneration between the teeth and gingival margin, or external ear canal for example, temporary joint spacers, and other short term uses according to the surgeon's determination. Durasil II (Long Term) Nonreinforced - Tympanic membrane repair, dural covering .00S inch, nasal septal repair, tendon anastomosis, neural repair - .007 inch. correction of strabismus .010 inch, galea vrepair - .020 inch, orbital floor repair .040inch, hemodialysis shunt anchors .060. Reinforced - Facilitation of osteogenesis .007inch, repair of urethral strictures .007inch, staged repair of omphaloccel .020inch, repair of orbital floor fractures .040inch.

Source page: https://510kreport.com/device/K973730
Methodology: https://510kreport.com/methodology