Hobbs Posi-Stop Injection Needle 4712S-01

GUDID M8494712S010

A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.

HOBBS MEDICAL, INC.

General-purpose endoscopic needle, single-use

• Primary Device ID: M8494712S010
• NIH Device Record Key: e17cdae1-f43d-49b4-be29-eff9b7e19de8
• Commercial Distribution Discontinuation: 2025-11-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Hobbs Posi-Stop Injection Needle
• Version Model Number: 4712S-01
• Catalog Number: 4712S-01
• Company DUNS: 076769355
• Company Name: HOBBS MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com
• Phone: 8606845875
• Email: customerservice@hobbsmedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M8494712S010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K834403

FDA Product Code

• FBK: Endoscopic Injection Needle, Gastroenterology-Urology

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-11-24
• Device Publish Date: 2016-09-21

On-Brand Devices [Hobbs Posi-Stop Injection Needle]

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• M8494718S0: A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated t
• M8494714S010: A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated t
• M8494712S010: A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated t
• M8494712S0: A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated t