# K072470: Bioelast 5-0 Suture, Model 500100

- Pathway: 510(k) (Traditional)
- Applicant: Entrigue Surgical, Inc.
- Decided: Nov 16, 2007 after 73 days
- Product code: NWJ (Suture, Recombinant Technology)
- Device class: 2
- Regulation: 21 CFR 878.4494
- 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) TephaFLEX® Absorbable Suture: named in the summary without a submission number
- (no number) PDS*II: named in the summary without a submission number

## Indications for use
BioElastTM 5-0 absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Source page: https://510kreport.com/device/K072470
Methodology: https://510kreport.com/methodology