← Product Code [EGM](/submissions/DE/subpart-e%E2%80%94surgical-devices/EGM) · K864294

# HENKE-JECT PRESSURE SYRINGE (MODIFICATION) (K864294)

_Smith & Nephew, Inc. · EGM · Nov 4, 1987 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGM/K864294

## Device Facts

- **Applicant:** Smith & Nephew, Inc.
- **Product Code:** [EGM](/submissions/DE/subpart-e%E2%80%94surgical-devices/EGM.md)
- **Decision Date:** Nov 4, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.4475
- **Device Class:** Class 2
- **Review Panel:** Dental

## Regulatory Identification

A spring-powered jet injector is a syringe device intended to administer a local anesthetic. The syringe is powered by a spring mechanism which provides the pressure to force the anesthetic out of the syringe.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGM/K864294](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/EGM/K864294)

**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