# K031639: Intermed Zoom Colposcope

- Pathway: 510(k) (Traditional)
- Applicant: Intermed Group, Inc.
- Decided: Aug 22, 2003 after 87 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
Longest line of descent: 1 generation back to K853389 (1985). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913365: Accuscope (TM) & Accuscope II (TM), Vineland Medical Products, Inc. (1992) Summary page 1.
- K853389: Wallach Zoom Colposcope, Wallach Surgical Devices, Inc. (1985) Summary page 1.
- K902313: LM-1Z Zoom Scope, Leisegang Medical, Inc. (1990) Summary page 1.

## Most influential descendants
- K132423: The Gynocular (2014), 0 descendants of its own
- K073053: Colpo-Master (2007), 0 descendants of its own

## Indications for use
The Intermed Zoom Colposcope is intended for direct magnified viewing of the cervix, vagina, and external genitalia for the purpose of diagnosing abnormalities and selecting areas for biopsy.

Source page: https://510kreport.com/device/K031639
Methodology: https://510kreport.com/methodology