LASE Curved Operating Channel Set

FDA UDI

Class II (US FDA UDI)

by Clarus Medical, Llc

Identity

Trade Name: LASE Curved Operating Channel Set FDA UDI
Generic Name: Lumbar decompression procedure kit FDA UDI
Device Name: LASE Curved Operating Channel Set for use with 1100-002 or 1100-010 Endoscopes. FDA UDI
Model / Reference: 1100-905 FDA UDI
Description: LASE Curved Operating Channel Set for use with 1100-002 or 1100-010 Endoscopes. FDA UDI

Identifiers

Catalog Number: 1100-905 FDA UDI
Primary DI / UDI-DI: B06711009051 FDA UDI
510(k) Number: K922881 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Lumbar decompression procedure kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4810 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

Yes

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

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 2.7 Millimeter FDA UDI
Length — 19.9 Centimeter FDA UDI

Category: Lumbar decompression procedure kit

LASE Curved Operating Channel Set by Clarus Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K922881 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: Clarus Medical, Llc

Sources (1)

FDA UDI 476f65d7-836c-4049-b9f0-1a0b3e1b6b98 38 fields · synced Jun 8, 2026