Turbett Surgical Instrument Pod (TS1500, TS1200, TS1000)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K250011 FDA 510(k)
- FDA Product Code
- FRG FDA 510(k)
- Models / Variants
- Turbett Surgical Instrument Pod (TS1500) FDA 510(k)Turbett Surgical Instrument Pod (TS1200) FDA 510(k)Turbett Surgical Instrument Pod (TS1000) FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.6850 FDA 510(k)
- Regulation Number
- 880.6850 FDA 510(k)
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Turbett Surgical Instrument Pod is a sterilization container designed to enclose other medical devices for processing by a healthcare provider. It is intended to facilitate the sterilization of enclosed materials and maintain their sterility for up to 30 days until the time of use.
These pods are FDA-cleared and designed to hold complete surgical sets. The system utilizes a single-use filter and is available in models TS1500, TS1200, and TS1000.
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: Home - Turbett Surgical, Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument ..., Turbett Surgical Pods — Grole Industries, Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250011 | Class II | Active |
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Manufacturer
- Manufacturer
- Turbett Surgical
Sources (1)
- FDA 510(k) K250011 24 fields · synced Oct 6, 2026