Identifiers
- 510(k) Number
- K924481 FDA 510(k)
- FDA Product Code
- HIF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.1730 FDA 510(k)
- Regulation Number
- 884.1730 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Insufflation tubing is a device used to deliver gas for insufflation during laparoscopic procedures. It is classified as a Class II medical device and is substantially equivalent to a predicate device cleared under the 510(k) process.
The device is manufactured by Applied Medical Resources and is authorized under FDA 510(k) clearance K924481. It is intended for use in obstetrics and gynecology applications and is supplied as a non-sterile, reusable component requiring appropriate cleaning and sterilization between uses.
Frequently asked questions
What is the insufflation tubing used for?
The insufflation tubing is used to deliver gas for insufflation during laparoscopic procedures, specifically intended for obstetrics and gynecology applications as stated in the device description.
Is the insufflation tubing sterile or non-sterile, and is it single-use or reusable?
The device is supplied as a non-sterile, reusable component, meaning it must undergo appropriate cleaning and sterilization between uses to ensure safe reuse in clinical settings.
What regulatory authorization does the insufflation tubing have?
The insufflation tubing is authorized under FDA 510(k) clearance K924481, indicating it is substantially equivalent to a predicate device and classified as a Class II medical device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: GelPOINT Path Transanal Procedural Pack | Applied Medical, GelPOINT Path Transanal Access Platform | Applied Medical, PDF PRODUCT CATALOG - Applied Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K924481 | Class II | Active |
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Manufacturer
- Manufacturer
- Applied Medical Resources
Sources (1)
- FDA 510(k) K924481 24 fields · synced Sep 24, 2026