← Product Code [OCL](/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL) · K011040

# CRYOCARE CARDIAC SURGICAL SYSTEM (K011040)

_Endocare, Inc. · OCL · Jun 15, 2001 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94surgical-devices/OCL/K011040

## Device Facts

- **Applicant:** Endocare, Inc.
- **Product Code:** [OCL](/submissions/SU/subpart-e%E2%80%94surgical-devices/OCL.md)
- **Decision Date:** Jun 15, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4400
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94surgical-devices/OCL/K011040](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94surgical-devices/OCL/K011040)

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