# K101141: Seiler Colposcope, Models 935, 955 and 985

- Pathway: 510(k) (Traditional)
- Applicant: Seiler Precision Microscopes
- Decided: Aug 6, 2010 after 106 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: 3 generations back to K940094 (1995). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021854: DFV CPG Colposcope, D.F. Vasconcellos S.A. (2002) Summary page 2.
- K884934: Jedmed KP6 Colposcope, Jedmed Instrument Co. (1989) Summary page 2.
- K940094: Colposcopes and Accessories, Leisegang Medical, Inc. (1995) Summary page 2.

## Indications for use
The Seiler colposcope is intended to provide magnified visualization of the tissues of the vulva, vagina, cervix, and anogenital area. It is used to evaluate these tissues, select areas for biopsy, as necessary, and to facilitate related procedures, e.g., LEEP, conization, etc.

Source page: https://510kreport.com/device/K101141
Methodology: https://510kreport.com/methodology