Myosure Reach Tissue Removal Device 10-401FC

GUDID 25420045504537

The MyoSure Tissue Removal System is intended for hysteroscopic intrauterine resection procedures by a trained gynecologist to hysteroscopically resect and remove tissue such as submucous myomas, endometrial polyps, and retained products of conception.

Hologic, Inc.

Tissue morcellation system

• Primary Device ID: 25420045504537
• NIH Device Record Key: 48a75ec9-2ef1-4bf2-8a5a-3807e46502dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Myosure Reach Tissue Removal Device
• Version Model Number: 10-401FC
• Catalog Number: 10-401FC
• Company DUNS: 018925968
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045504530 [Primary]
GS1	25420045504537 [Package]; Contains: 15420045504530; Package: CARTON [1 Units]; In Commercial Distribution
GS1	35420045504534 [Package]; Package: BOX [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152723

FDA Product Code

• HIH: HYSTEROSCOPE (AND ACCESSORIES)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-03
• Device Publish Date: 2023-07-26

Devices Manufactured by Hologic, Inc.

• 15420045517394 - Hologic: 2025-09-05 NG Res Primers Analyte Specific Reagent.
• 15420045517400 - Hologic: 2025-09-05 NG Res Probe (FAM) Analyte Specific Reagent.
• 15420045517417 - Hologic: 2025-09-05 NG Res C272T IVT Control (Positive Control).
• 15420045517424 - Hologic: 2025-09-05 NG IVT Wild Type Control (Negative Control).
• 15420045512412 - DEFINITY CERVICAL DILATOR, 5MM: 2025-07-29
• 15420045512429 - DEFINITY CERVICAL DILATOR, 7MM: 2025-07-29
• 15420045512436 - DEFINITY CERVICAL DILATOR, 9MM: 2025-07-29
• 15420045517097 - DIGITAL DIAGNOSTICS SYSTEM: 2025-07-25 Computer to operate the Genius™ Review Station.