# K110724: Surgical Procedure Packs

- Pathway: 510(k) (Traditional)
- Applicant: Omnia Spa
- Decided: Jun 23, 2011 after 99 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K934688 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041080: Surgical Drape Kit - D.I.R.R.a. SRL, D.I.R.R.a. S.R.L. (2004) Summary page 1.

## Indications for use
Surgical Procedure Packs are kits for oral implantology, used by dental professionals when performing surgical procedures. Surgical Procedure Packs are composed of disposable devices intended for professional use in preparing the operating environment with protective coverings and clothes that aid in maintaining cleanliness and limiting risk of contamination during various types of medical and/or dental surgeries.

Source page: https://510kreport.com/device/K110724
Methodology: https://510kreport.com/methodology