DEVICE: Myosure XL for Fluent Device (15420045507654)

Device Identifier (DI) Information

Myosure XL for Fluent Device
50-601XL
In Commercial Distribution
50-601XL
Hologic, Inc.
15420045507654
GS1

1
018925968 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46729 Tissue morcellation system
An assembly of devices used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body (a process known as morcellation), typically during laparoscopic surgery (e.g., for tumour or fibroid removal). It typically consists of a handpiece (high-speed rotating blade and holder) for tissue resection and extraction, a mains electricity (AC-powered) control unit that drives the handpiece blade, a remote drive cable to connect the handpiece with the control unit, and a foot-switch; some designs may also provide suction intended for removal of resected tissue.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HIH HYSTEROSCOPE (AND ACCESSORIES)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K181974 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

c44e5995-3a6a-4a59-aad5-644f7f2015a4
September 04, 2023
3
September 26, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
45420045507655 3 25420045507651 In Commercial Distribution CARTON
25420045507651 1 15420045507654 In Commercial Distribution BOX
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)442-9892
CustomerSupport@hologic.com
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