# K874813: Omed Wound Closure Strips

- Pathway: 510(k) (Traditional)
- Applicant: Oxboro Medical Intl., Inc.
- Decided: Jan 29, 1988 after 66 days
- Product code: FPX (Strip, Adhesive, Closure, Skin)
- Device class: 1
- Regulation: 21 CFR 880.5240
- Recalls of this device: 1 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jul 18, 2013 · Class II · Z-1988-2013: Aspen Surgical is recalling Wound Closures because firm could not confirm sterility, after FDA sampling indicated the product may not be sterile. Using the recalled product could lead to infection whi

Source page: https://510kreport.com/device/K874813
Methodology: https://510kreport.com/methodology