← Product Code [ERL](/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL) · K943569

# STRYKER TOTAL PERFORMANCE SYSTEM (K943569)

_Stryker Corp. · ERL · Jan 9, 1995 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K943569

## Device Facts

- **Applicant:** Stryker Corp.
- **Product Code:** [ERL](/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL.md)
- **Decision Date:** Jan 9, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.4250
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K943569](https://fda.innolitics.com/submissions/EN/subpart-e%E2%80%94surgical-devices/ERL/K943569)

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