# K052420: G-Spec Articulated Weighted Vaginal Speculum

- Pathway: 510(k) (Traditional)
- Applicant: Gynova, LLC
- Decided: Apr 6, 2006 after 216 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
Longest line of descent: 1 generation back to K000414 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000414: Medisul Disposable Vaginal Speculum, Marketing Perspectives (2000) Summary page 1.
- K030693: Kentex Disposable Vaginal Speculum, Kentron Health Care, Inc. (2003) Summary page 1.
- K042950: Vag O Speculum, Models VS1, VM1, VL1, Panatrex, Inc. (2004). Our reading of the summary gave K043950, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Vag O Speculum, Panatrex, Inc.”.
- (no number) Plastic Vaginal Speculum, Astralite Corp.: named in the summary without a submission number
- (no number) Auvard Weighted Vaginal Speculum, Cooper Surgical: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K002294: Biocheck Testosterone Eia, Model BC-1115, Biocheck, Inc. (2000). Our reading of the summary gave K002294, FDA’s number for Biocheck Testosterone Eia, Model BC-1115 (Biocheck, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Disposable Vaginal Speculum, Medical Action Industries, Inc.”. Kept off the family tree. Summary page 1.

## Indications for use
To retract and expose the interior of the vagina during general diagnostic and therapeutic gynecological and obstetric procedures.

Source page: https://510kreport.com/device/K052420
Methodology: https://510kreport.com/methodology