# K853389: Wallach Zoom Colposcope

- Pathway: 510(k) (Traditional)
- Applicant: Wallach Surgical Devices, Inc.
- Decided: Nov 19, 1985 after 98 days
- Product code: HEX (Colposcope (And Colpomicroscope))
- Device class: 2
- Regulation: 21 CFR 884.1630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 4 cite it directly.
0 of 9 devices 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.

## Most influential descendants
- K021854: DFV CPG Colposcope (2002), 4 descendants of its own
- K031639: Intermed Zoom Colposcope (2003), 2 descendants of its own
- K070845: Sounmed Coloposcope Colpo-99/99PLUS (2007), 1 descendant of its own
- K160341: Colposcope System (2016), 0 descendants of its own
- K132423: The Gynocular (2014), 0 descendants of its own

Source page: https://510kreport.com/device/K853389
Methodology: https://510kreport.com/methodology