Mammotome Revolve EX

FDA UDI

Class II (US FDA UDI)

by Devicor Medical Products, Inc.

Identity

Trade Name: Mammotome Revolve EX FDA UDI
Generic Name: Side-notch biopsy gun handpiece/needle FDA UDI
Device Name: Revolve EX Ultrasound Probe with Sleeve - CD FDA UDI
Model / Reference: MHEX08S FDA UDI
Description: Revolve EX Ultrasound Probe with Sleeve - CD FDA UDI

Identifiers

Catalog Number: CA000460003 FDA UDI
Primary DI / UDI-DI: 00841911102502 FDA UDI
510(k) Number: K202012 FDA UDI
FDA Product Code: KNW FDA UDI
GMDN Term: Side-notch biopsy gun handpiece/needle FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1075 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Side-notch biopsy gun handpiece/needle

Mammotome Revolve EX by Devicor Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Side-notch biopsy gun handpiece/needle.

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M-Biopsy — Mermaid Medical A/S · Class II
TOP CUT — H.S. HOSPITAL SERVICE SPA · Class II
M-Biopsy — Mermaid Medical A/S · Class II

Cleared under the same submission

K202012 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Devicor Medical Products, Inc.

Sources (1)

FDA UDI f920c900-2a3a-4c7c-98b2-bd7a138c8d47 35 fields · synced Jun 8, 2026