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FDA 510(k)

NOVASPINE POWERED SUCTION PUMP PRO-1

K-Number: K062456 · 2006-10-16

ApplicantNovaspine, LLC
Decision Date2006-10-16
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NOVASPINE POWERED SUCTION PUMP PRO-1 is the device name listed in this FDA 510(k) record. The listed applicant is Novaspine, LLC. It received FDA 510(k) clearance on 2006-10-16 under 510(k) number K062456. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVASPINE POWERED SUCTION PUMP PRO-1?

NOVASPINE POWERED SUCTION PUMP PRO-1 is a medical device that received FDA 510(k) clearance on 2006-10-16. The listed applicant is Novaspine, LLC. The 510(k) number is K062456.

When did NOVASPINE POWERED SUCTION PUMP PRO-1 receive FDA 510(k) clearance?

NOVASPINE POWERED SUCTION PUMP PRO-1 received FDA 510(k) clearance on 2006-10-16, under 510(k) number K062456.

Who is the listed applicant for NOVASPINE POWERED SUCTION PUMP PRO-1?

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

What is the FDA product code for NOVASPINE POWERED SUCTION PUMP PRO-1?

The FDA product code for NOVASPINE POWERED SUCTION PUMP PRO-1 is OMP.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Novaspine, 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.

K061133SIMEX SUCTION PUMP, MODELS AC20, AC20K, AC30, DC20, DC30 AND DC30SK051607NOVASPINE CEMENT RESTRICTOR NSCR

Related Devices (Code: OMP)

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.

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork MedicalK254019Wound Geni NPWT SystemBechtel Medical, Inc.

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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