# K013835: Global Healthcare Vaginal Speculum

- Pathway: 510(k) (Traditional)
- Applicant: Dynascend Consulting Int'L, LLC
- Decided: Jan 17, 2002 after 59 days
- Product code: HIB (Speculum, Vaginal, Nonmetal)
- Device class: 2
- Regulation: 21 CFR 884.4530
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Global Healthcare's Vaginal Speculum is intended to be used for general gynecological/electrosurgical procedures. It is inserted into the vagina to expose the cervix.

Source page: https://510kreport.com/device/K013835
Methodology: https://510kreport.com/methodology