# K983630: Seare Biomedical Silicone Rods

- Pathway: 510(k) (Traditional)
- Applicant: Seare Biomedical Corp.
- Decided: Dec 11, 1998 after 57 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.
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) Sil-Tec Rod: named in the summary without a submission number
- (no number) silicone rods: named in the summary without a submission number

## Indications for use
Seare Biomedical Silicone Rods are intended for use in the cosmetic correction of soft tissue deformities, and are shaped at the surgeon’s discretion to create an implant to aid in the reconstruction process. Some uses have been as temporary stents for the formation of new tendon sheaths, as well as other uses in surgical repair procedures demanding a highly inert and flexible rod shaped material as deemed appropriate by the using surgeon.

Source page: https://510kreport.com/device/K983630
Methodology: https://510kreport.com/methodology