Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ALPHAMED SURGICAL SPEAR, MODEL 70-5000

K-Number: K091240 · 2009-10-23

ApplicantAlphamed, Inc.
Decision Date2009-10-23
Product CodeHOZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ALPHAMED SURGICAL SPEAR, MODEL 70-5000 is the device name listed in this FDA 510(k) record. The listed applicant is Alphamed, Inc.. It received FDA 510(k) clearance on 2009-10-23 under 510(k) number K091240. The device is classified under product code HOZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHAMED SURGICAL SPEAR, MODEL 70-5000?

ALPHAMED SURGICAL SPEAR, MODEL 70-5000 is a medical device that received FDA 510(k) clearance on 2009-10-23. The listed applicant is Alphamed, Inc.. The 510(k) number is K091240.

When did ALPHAMED SURGICAL SPEAR, MODEL 70-5000 receive FDA 510(k) clearance?

ALPHAMED SURGICAL SPEAR, MODEL 70-5000 received FDA 510(k) clearance on 2009-10-23, under 510(k) number K091240.

Who is the listed applicant for ALPHAMED SURGICAL SPEAR, MODEL 70-5000?

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

What is the FDA product code for ALPHAMED SURGICAL SPEAR, MODEL 70-5000?

The FDA product code for ALPHAMED SURGICAL SPEAR, MODEL 70-5000 is HOZ.

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 Alphamed, 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.

K190210Tear Pool Dissolvable Punctum PlugsK990321ALPHAMED GEMINI SENSOR, SNORING SENSORK926446EZ PUMP

Related Devices (Code: HOZ)

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.

K132796SUNTOUCH EYE SPEARHuizhou Foryou Medical Devices Co., Ltd.K130117NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDSNetwork Medical Products, Ltd.K082460CENEFOM PVA SURGICAL SPEARLongtek Scientific Co., Ltd.K012196ULTRACELL ABSORBENT STICKUltracell Medical Technologies, Inc.K011191MEROCEL CORNELL LID AND LASH GUARD, MEROCEL AND KEROCEL OPHTHALMIC SPONGESMedtronic Xomed, Inc.K003842PRESCOTT'S SURGICAL SPEARPrescott'S, 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.

↑