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FDA 510(k)

SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901

K-Number: K002970 · 2000-12-12

ApplicantMedical Designs, LLC
Decision Date2000-12-12
Product CodeJXG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Designs, LLC. It received FDA 510(k) clearance on 2000-12-12 under 510(k) number K002970. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901?

SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 is a medical device that received FDA 510(k) clearance on 2000-12-12. The listed applicant is Medical Designs, LLC. The 510(k) number is K002970.

When did SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 receive FDA 510(k) clearance?

SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 received FDA 510(k) clearance on 2000-12-12, under 510(k) number K002970.

Who is the listed applicant for SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901?

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

What is the FDA product code for SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901?

The FDA product code for SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 is JXG.

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Other records listing Medical Designs, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182352SP-LINK™ SystemK181591Fixated Asfora BULLET CAGE® (FABC)K112648ASFORA BULLET CAGEK090048ASFORA BULLET CAGE SYSTEMK042359SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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