Inzone Detachment System
FDA 510(k) K120816 · Stryker
510(k) numberK120816
Submission
- Device name
- Inzone Detachment System
- Applicant
- Stryker
Fremont, CA, US - Received
- March 19, 2012
- Decision date
- April 17, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRD – Device, Vascular, For Promoting Embolization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3300
- Specialty
- Cardiovascular
- Implant
- Yes
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| K253376 | OBSIDIO Conformable Embolic (M0013972101010)KRD · Special | Boston Scientific Corporation | 10/30/2025SE |
| K250209 | Polyvinyl Alcohol Embolic MicrospheresKRD · Traditional | Canyon Medical, Inc. | 09/23/2025SE |
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Questions and answers
When was Inzone Detachment System cleared by the FDA?
Inzone Detachment System (K120816) received a 510(k) decision of Substantially Equivalent on April 17, 2012, 29 days after the submission was received.
What is the product code of K120816?
The FDA product code is KRD – Device, Vascular, For Promoting Embolization, a Class II (moderate risk) device regulated under 21 CFR 870.3300.