# K050256: Apple Medical/OB Mobius Elastic Retractor

- Pathway: 510(k) (Traditional)
- Applicant: Apple Medical Corp.
- Decided: Apr 26, 2005 after 82 days
- Product code: GAD (Retractor)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K954824 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041131: Apple Medical OB Mobius Elastic Retractor, Apple Medical Corp. (2004) Summary page 1.
- (no number) 510(k) exempt mechanical abdominal retractors used in cesarean section: named in the summary without a submission number

## Indications for use
The Apple Medical OB/Mobius Elastic Retractor is indicated for use to assist in non-urgent cesarean deliveries that are routine procedures. It is intended to provide incision retraction and to protect against wound contamination during a cesarean section. It is indicated for use as a surgical retractor for both vertical and transverse incisions.

Source page: https://510kreport.com/device/K050256
Methodology: https://510kreport.com/methodology