Accu-Space Plain Gut Absorbable Seeding Spacers
FDA 510(k)Class II (US FDA 510(k))
by Cp Medical
Identifiers
- 510(k) Number
- K013964 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 Plain Gut Absorbable Seeding Spacers are cylindrical, absorbable spacer devices designed to create and maintain separation between radionuclide seeds during brachytherapy implantation. These spacers are intended for use in radiology procedures to ensure proper seed distribution within the target tissue, aiding in the precision of radiation delivery.
Supplied as a single-use device, these spacers are intended for sterile application in clinical settings. They fall under FDA regulation 892.5730 and were granted a Special 510(k) clearance under the Radiology advisory committee in 2002. The product code is KXK, and the device is classified as Class II. No reusable or MRI-specific considerations are noted in the specifications.
Frequently asked questions
What is the primary purpose of the Accu-Space Plain Gut Absorbable Seeding Spacers in a clinical setting?
The Accu-Space Plain Gut Absorbable Seeding Spacers are designed to create and maintain separation between radionuclide seeds during brachytherapy procedures. This ensures proper seed distribution within the target tissue, which improves the precision of radiation delivery in radiology-based treatments.
Are these spacers intended for single-use or reusable applications, and why?
These spacers are explicitly intended for single-use only. The manufacturer specifies them as sterile devices meant for clinical application without reuse, aligning with standard practices for absorbable medical devices to prevent contamination and ensure patient safety.
What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its use?
The device received a Special 510(k) clearance under the Radiology advisory committee in 2002, classified as Class II under FDA regulation 892.5730. This means it was determined to be substantially equivalent to a legally marketed predicate device, allowing its use in radiology procedures for brachytherapy seed spacing while adhering to FDA standards for safety and effectiveness.
How should these spacers be stored, and is there any special handling required?
While the data does not specify storage conditions explicitly, as a sterile, single-use medical device, these spacers should be stored in a clean, dry environment protected from contamination, moisture, and extreme temperatures. Always follow the manufacturer’s instructions (if available) or standard sterile device storage protocols to maintain integrity until use.
Are there any known limitations or considerations regarding MRI compatibility or reuse for this device?
The device specifications do not mention any MRI-specific considerations, meaning there is no documented compatibility or restriction related to MRI use. Additionally, since it is explicitly single-use, there are no guidelines or approvals for reuse, reinforcing the need to treat each package as sterile and non-reusable.
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: Modification to Accu-space Plain Gut Absorbable Seeding Spacers, MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS 510 (k ..., PDF K013964 Modification to Accu-space Plain Gut Absorbable Seeding Spacers, Cp Accu-Space Plain Gut Absorbable Seeding Spacers
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K013964 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cp Medical
Sources (1)
- FDA 510(k) K013964 24 fields · synced Sep 19, 2026