← Product Code [FWF](/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF) · K905393

# HC-SERIES MEDICAL CAMERA/LIGHT SOURCE AND ACCESSOR (K905393)

_Frigitronics, Inc. · FWF · Jan 16, 1991 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K905393

## Device Facts

- **Applicant:** Frigitronics, Inc.
- **Product Code:** [FWF](/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF.md)
- **Decision Date:** Jan 16, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4160
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

A surgical camera and accessories is a device intended to be used to record operative procedures.

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K905393](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FWF/K905393)

**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