# K992736: Wallach's Ultimate Reusable, Plastic Vaginal Speculum

- Pathway: 510(k) (Traditional)
- Applicant: Wallach Surgical Devices, Inc.
- Decided: Sep 29, 1999 after 47 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 K935636 (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)
- K935636: Gravespec, Adept-Med Intl., Inc. (1994) Summary page 1.
- K951898: Versa-VU, CooperSurgical, Inc. (1995) Summary page 1.

## Indications for use
The Wallach Ultimate Reusable, Plastic Vaginal Speculum is intended to be used for general gynecologic and electrosurgical procedures. This product is inserted into the vagina to expose the cervix.

Source page: https://510kreport.com/device/K992736
Methodology: https://510kreport.com/methodology