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FDA 510(k)

HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)

K-Number: K113088 · 2012-05-02

ApplicantInnerspace, Inc.
Decision Date2012-05-02
Product CodeGWM
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) is the device name listed in this FDA 510(k) record. The listed applicant is Innerspace, Inc.. It received FDA 510(k) clearance on 2012-05-02 under 510(k) number K113088. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)?

HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) is a medical device that received FDA 510(k) clearance on 2012-05-02. The listed applicant is Innerspace, Inc.. The 510(k) number is K113088.

When did HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) receive FDA 510(k) clearance?

HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) received FDA 510(k) clearance on 2012-05-02, under 510(k) number K113088.

Who is the listed applicant for HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)?

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

What is the FDA product code for HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)?

The FDA product code for HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) is GWM.

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Other records listing Innerspace, Inc. 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.

K083378SYNERGYK072379MPS OXIPORT AND MPS OXIPORT PLUSK041838MPS (OR MPS-T)K013705ACT III VENTRICULAR CATHETERK013005ACT 11 MP VENTRICULAR CATHETERK010422ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER

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Related Devices (Code: GWM)

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.

K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysaK250285NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOLRaumedic AGK240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A.K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production CorporationK201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP MonitorIntegra Lifesciences Production Corporation

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.

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