# K972630: Coopersurgical Digital Colposcopy System

- Pathway: 510(k) (Traditional)
- Applicant: CooperSurgical, Inc.
- Decided: Feb 2, 1998 after 203 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 K940094 (1995). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940094: Colposcopes and Accessories, Leisegang Medical, Inc. (1995) Summary page 2.
- K955635: Video Colposcope/Vertical Rolling Base/Swing Arm Stand, Welch Allyn, Inc. (1996) Summary page 2.

## Most influential descendants
- K092433: DYSIS (2011), 0 descendants of its own

## Indications for use
The CooperSurgical Digital Colposcopy System combines a standard colposcope with a computer-based Digital Documentation System. The colposcope is intended to permit direct magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The Digital Documentation System is intended to provide documentation of the image in the field of view of the colposcope. The image can be viewed on a color monitor, printed on a color printer, or archived for storage and subsequent retrieval.

Source page: https://510kreport.com/device/K972630
Methodology: https://510kreport.com/methodology