← Product Code [HSZ](/submissions/SU/subpart-e%E2%80%94surgical-devices/HSZ) · K942760

# PNEUMATIC WIRE TENSIONER (K942760)

_Smith & Nephew Richards, Inc. · HSZ · Sep 6, 1994 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HSZ/K942760

## Device Facts

- **Applicant:** Smith & Nephew Richards, Inc.
- **Product Code:** [HSZ](/submissions/SU/subpart-e%E2%80%94surgical-devices/HSZ.md)
- **Decision Date:** Sep 6, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4820
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

---

**Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HSZ/K942760](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HSZ/K942760)

**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