FDA 510(k)

EMBRYON ULTRASOUND NEEDLE GUIDE

K-Number: K032015 · 2003-08-08

Decision Date2003-08-08

Product CodeMQE

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

EMBRYON ULTRASOUND NEEDLE GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is Rocket Medical Plc. It received FDA 510(k) clearance on 2003-08-08 under 510(k) number K032015. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMBRYON ULTRASOUND NEEDLE GUIDE?

EMBRYON ULTRASOUND NEEDLE GUIDE is a medical device that received FDA 510(k) clearance on 2003-08-08. The listed applicant is Rocket Medical Plc. The 510(k) number is K032015.

When did EMBRYON ULTRASOUND NEEDLE GUIDE receive FDA 510(k) clearance?

EMBRYON ULTRASOUND NEEDLE GUIDE received FDA 510(k) clearance on 2003-08-08, under 510(k) number K032015.

Who is the listed applicant for EMBRYON ULTRASOUND NEEDLE GUIDE?

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

What is the FDA product code for EMBRYON ULTRASOUND NEEDLE GUIDE?

The FDA product code for EMBRYON ULTRASOUND NEEDLE GUIDE is MQE.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Rocket Medical Plc as applicant

K210509Rocket Platinum Cured Cathter K163321Rocket Indwelling Pleural Catheter (IPC) Insertion Kit K162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion Kit K152105Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set K123033ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE B K052365CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE

View all 19 devices →

Related Devices (Code: MQE)

K253121Giftlife Single Lumen Oocyte Retrieval Needle, Giftlife Double Lumen Oocyte Retrieval NeedleGimbo Medical Technology Shenzhen Co., Ltd.K240523VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)Shenzhen Vitavitro Biotech Co., Ltd.K232163Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration NeedleZhejiang Horizon Medical Technology Co., Ltd.K190590Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)Allwin Medical Devices, Inc.K191291Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, Inc.K182959Wallace Dual Lumen Oocyte Recovery SystemCooperSurgical, 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.