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FDA 510(k)

HSV STRAW

K-Number: K092398 · 2010-10-06

ApplicantCryo Bio System
Decision Date2010-10-06
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HSV STRAW is the device name listed in this FDA 510(k) record. The listed applicant is Cryo Bio System. It received FDA 510(k) clearance on 2010-10-06 under 510(k) number K092398. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HSV STRAW?

HSV STRAW is a medical device that received FDA 510(k) clearance on 2010-10-06. The listed applicant is Cryo Bio System. The 510(k) number is K092398.

When did HSV STRAW receive FDA 510(k) clearance?

HSV STRAW received FDA 510(k) clearance on 2010-10-06, under 510(k) number K092398.

Who is the listed applicant for HSV STRAW?

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

What is the FDA product code for HSV STRAW?

The FDA product code for HSV STRAW is MQK.

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 Cryo Bio System 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.

K002595CBS STRAW

Related Devices (Code: MQK)

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.

K241626SperSort™ Sperm Sorting Chip (IPG02)Ipreg IncorporationK241454Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)Guangzhou Hehong Biotech Co., Ltd.K241348SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)Motilitycount ApsK241341cryo-GO Vitrification DeviceFujifilm Irvine ScientificK240002G-Vitri™ Vitrification StrawGimbo Medical Technology Shenzhen Co., Ltd.K232980SpermAlign Sperm Separation DeviceCytoswim, Ltd.

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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