← Product Code [HEX](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX) · K760763

# COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I (K760763)

_Dynatech Cryomedical Co. · HEX · Oct 20, 1976 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K760763

## Device Facts

- **Applicant:** Dynatech Cryomedical Co.
- **Product Code:** [HEX](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX.md)
- **Decision Date:** Oct 20, 1976
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.1630
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.

## Special Controls

*Classification.* Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.

---

**Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K760763](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HEX/K760763)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com