FDA 510(k)

External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters

K-번호: K242974 · 2025-06-20

결정일2025-06-20

제품 코드JXG

자문 위원회NE

결정Substantially Equivalent

기기 요약

External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Sophysa. It received FDA 510(k) clearance on 2025-06-20 under 510(k) number K242974. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters?

External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters is a medical device that received FDA 510(k) clearance on 2025-06-20. The listed applicant is Sophysa. The 510(k) number is K242974.

When did External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters receive FDA 510(k) clearance?

External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters received FDA 510(k) clearance on 2025-06-20, under 510(k) number K242974.

Who is the listed applicant for External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters?

The FDA 510(k) record lists Sophysa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters?

The FDA product code for External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters is JXG.

Sophysa를 신청인으로 등재한 기타 기록

K252241Pressio 3 Multi-parameter Neuromonitoring System K250636Sophy Mini Monopressure Valve (SM1)K222422Polaris Valve Electronic Reading Instrument

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