← Product Code [HAM](/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM) · K853291

# GP-100 ADULT ELECTROSURGICAL GROUND PAD/200 & 300 (K853291)

_Bio-Detek, Inc. · HAM · Oct 10, 1985 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K853291

## Device Facts

- **Applicant:** Bio-Detek, Inc.
- **Product Code:** [HAM](/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM.md)
- **Decision Date:** Oct 10, 1985
- **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/SU/subpart-e%E2%80%94surgical-devices/HAM/K853291](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HAM/K853291)

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