← Product Code [GBX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GBX) · K905422 # PVC ROUND WOUND DRAINS (K905422) _Axiom Medical, Inc. · GBX · Feb 11, 1991 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBX/K905422 ## Device Facts - **Applicant:** Axiom Medical, Inc. - **Product Code:** [GBX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GBX.md) - **Decision Date:** Feb 11, 1991 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4200 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery ## Regulatory Identification An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBX/K905422](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBX/K905422) **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 as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBX/K905422