# K863764: Cotton Rolls, Non-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: The Medical Group, Inc.
- Decided: Oct 27, 1986 after 32 days
- Product code: EFN (Cotton, Roll)
- Device class: 1
- Regulation: 21 CFR 872.6050
- Recalls of this device: 2 (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
- Aug 12, 2013 · Class II · Z-2158-2013: A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility
- Aug 12, 2013 · Class II · Z-2159-2013: A medical device used in surgical procedures was packaged in a pouch in which a defective seal may compromise sterility

Source page: https://510kreport.com/device/K863764
Methodology: https://510kreport.com/methodology