← Product Code [HBA](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA) · K950647

# ULTRACELL NEURO SPONGES (K950647)

_Ultracell Medical Technologies, Inc. · HBA · Aug 15, 1995 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K950647

## Device Facts

- **Applicant:** Ultracell Medical Technologies, Inc.
- **Product Code:** [HBA](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA.md)
- **Decision Date:** Aug 15, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.4700
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

A neurosurgical paddie is a pad used during surgery to protect nervous tissue, absorb fluids, or stop bleeding.

---

**Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K950647](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBA/K950647)

**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