Accu-Space Absorbable Seeding Spacers
FDA 510(k)Class II (US FDA 510(k))
by Cp Medical
Identifiers
- 510(k) Number
- K010621 FDA 510(k)
- FDA Product Code
- KXK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5730 FDA 510(k)
- Regulation Number
- 892.5730 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Accu-Space Absorbable Seeding Spacers are small, cylindrical devices designed as absorbable spacer components for brachytherapy procedures. These spacers are intended to create and maintain separation between radionuclide seeds during implantation, ensuring proper distribution and reducing potential seed clustering within the target tissue.
These spacers are supplied as single-use, absorbable devices and are classified under FDA regulation 892.5730 as Class II medical devices. They are used in radiology settings for brachytherapy applications and are approved under the FDA’s 510(k) clearance process (K010621). The devices are sterile upon packaging and intended for one-time clinical use, with no MRI safety restrictions specified.
Frequently asked questions
What are the Accu-Space Absorbable Seeding Spacers used for?
These spacers are designed specifically for brachytherapy procedures to create and maintain separation between radionuclide seeds during implantation. By preventing seed clustering, they help ensure proper distribution within the target tissue, improving the accuracy and effectiveness of radiation delivery.
Are the Accu-Space Absorbable Seeding Spacers single-use or reusable?
The Accu-Space Absorbable Seeding Spacers are intended for single-use only. This design ensures sterility and safety for each clinical procedure, as reuse could compromise device integrity and patient safety.
How are the spacers supplied, and are they sterile?
The spacers are supplied sterile upon packaging, ready for immediate clinical use. They are absorbable, meaning they dissolve over time after implantation, eliminating the need for removal.
What regulatory pathway does the Accu-Space Absorbable Seeding Spacers follow?
The device is classified under FDA regulation 892.5730 as a Class II medical device and has received FDA 510(k) clearance (K010621). This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and meets applicable safety and performance standards.
Are there any special considerations for storage or handling?
Since the spacers are sterile upon packaging and intended for single-use, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Follow manufacturer guidelines to maintain sterility until use, and avoid contamination or damage to the packaging.
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: ACCU-SPACE ABSORBABLE SEEDING SPACERS - Innolitics, PDF K013964 - Food and Drug Administration, Accu-space Absorbable Seeding Spacers - Beudamed, Cp Accu-Space Absorbable Seeding Spacers - allmed.wiki
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K010621 | Class II | Active |
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Manufacturer
- Manufacturer
- Cp Medical
Sources (1)
- FDA 510(k) K010621 24 fields · synced Oct 1, 2026