VersaCut+ Sterile Outer Blade

FDA UDI

Class II (US FDA UDI)

by Lumenis

Identity

Trade Name: VersaCut+ Sterile Outer Blade FDA UDI
Generic Name: Tissue morcellation system FDA UDI
Model / Reference: VersaCut+ Sterile Outer Blade FDA UDI

Identifiers

Primary DI / UDI-DI: 07290109143156 FDA UDI
510(k) Number: K133272 FDA UDI
FDA Product Code: GCJ FDA UDI
GMDN Term: Tissue morcellation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 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

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tissue morcellation system

VersaCut+ Sterile Outer Blade by Lumenis — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tissue morcellation system.

SUPERCUT — Karl Storz GmbH & Co. KG · Class II
TruClear — Covidien LP · Class II
MultiCut Solo — Asclepion Laser Technologies GmbH · Class II
MultiCut Blade 400 — Asclepion Laser Technologies GmbH · Class II
BLUEENDO — TROKAMED GmbH · Class II
BLUEENDO — TROKAMED GmbH · Class II
TruClear — Covidien LP · Class II
NICO Myriad — NICO Corporation · Class II

Cleared under the same submission

K133272 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Lumenis

Sources (1)

FDA UDI 49c474e5-e550-40f7-8deb-2015f4fa4768 34 fields · synced Jun 1, 2026