Latex Penrose Tubing Cat. #20400, 414, 416
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K802761 FDA 510(k)
- FDA Product Code
- GAZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.6740 FDA 510(k)
- Regulation Number
- 880.6740 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Latex Penrose Tubing Cat. #20400, 414, 416 is a tubing, noninvasive (FDA Product Code GAZ) designed for medical drainage applications. Constructed from latex, this tubing is intended to facilitate fluid drainage in clinical settings, such as wound or surgical sites, by providing a flexible, low-resistance pathway for fluids to exit the body.
Supplied as a single-use device, the tubing is intended for use in general hospital environments. It is not sterilized by the manufacturer and must be sterilized prior to use, typically via autoclave or chemical sterilization methods. The device carries an FDA 510(k) clearance (K802761) under the Traditional review pathway, with a decision date of November 19, 1980. No MRI safety information is specified, and sizes are identified by the catalog numbers 20400, 414, and 416.
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: LATEX PENROSE TUBING CAT. #20400,414,416 (K802761) — FDA 510 (k ..., Latex Penrose Tubing Cat. #20400,414,416 510 (k) FDA Premarket ..., PDF K802761 - Latex Penrose Tubing Cat. #20400,414,416, LATEX PENROSE TUBING (K822755) — FDA 510(k) | Innolitics, FDA Product Code GAZ - Tubing, Noninvasive
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K802761 | Class II | Active |
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Manufacturer
- Manufacturer
- American Hospital Supply Corp.
Sources (1)
- FDA 510(k) K802761 24 fields · synced Sep 19, 2026