# K971095: Opportunity Suture Removal Kit

- Pathway: 510(k) (Traditional)
- Applicant: Opportunity, Inc.
- Decided: Sep 16, 1997 after 176 days
- Product code: EFQ (Gauze/Sponge, Internal)
- Device class: U
- 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 no predicate by number.

## Indications for use
Opportunity Inc.’s Suture Removal Kit is intended for use by a licensed professional or other medical personnel as deemed appropriate by the using facility. The intended use of the medical products assembled in these kits will not change from the manufacturers original intended use. This kit is used for performing or assisting in performing suture removal.

Source page: https://510kreport.com/device/K971095
Methodology: https://510kreport.com/methodology