SER Pen Carain MicroSystem (MP1209SP)
K-Number: K253153 · 2025-10-29
ApplicantSu-Ko Technologies, LLC
Decision Date2025-10-29
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SER Pen Carain MicroSystem (MP1209SP) is a medical device manufactured by Su-Ko Technologies, LLC. It received FDA 510(k) clearance on 2025-10-29 under approval number K253153. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SER Pen Carain MicroSystem (MP1209SP)?
SER Pen Carain MicroSystem (MP1209SP) is a medical device that received FDA 510(k) clearance on 2025-10-29. It is manufactured by Su-Ko Technologies, LLC. The 510(k) number is K253153.
When was SER Pen Carain MicroSystem (MP1209SP) approved by the FDA?
SER Pen Carain MicroSystem (MP1209SP) received FDA 510(k) clearance on 2025-10-29, under approval number K253153.
What company makes SER Pen Carain MicroSystem (MP1209SP)?
SER Pen Carain MicroSystem (MP1209SP) is manufactured by Su-Ko Technologies, LLC.
What is the FDA product code for SER Pen Carain MicroSystem (MP1209SP)?
The FDA product code for SER Pen Carain MicroSystem (MP1209SP) is QAI.
Other Devices by Su-Ko Technologies, LLC
Related Devices (Code: QAI)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.