# K082750: Entact Septal Stapler, Model 610-00100

- Pathway: 510(k) (Traditional)
- Applicant: Entrigue Surgical, Inc.
- Decided: Jan 6, 2009 after 109 days
- Product code: OLL (Septal Stapler/Absorbable Staples)
- Device class: 2
- Regulation: 21 CFR 878.4750
- 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) Incisive Surgical, INSORBO Absorbable Staple: named in the summary without a submission number
- (no number) Ethicon Inc., Vicryl® Suture: named in the summary without a submission number

## Indications for use
The ENTactTM Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissues during nasal septal surgery.

Source page: https://510kreport.com/device/K082750
Methodology: https://510kreport.com/methodology