← Back to catalogue

SureBlade

FDA UDI

Class II (US FDA UDI)

by Clinicon Corp.

Identity

Trade Name
SureBlade FDA UDI
Generic Name
General/multiple surgical diode/carbon dioxide laser system FDA UDI
Device Name
SureBlade 6mm, Lance, double edged, (No. 13) FDA UDI
Model / Reference
2572 FDA UDI
Description
SureBlade 6mm, Lance, double edged, (No. 13) FDA UDI

Identifiers

Primary DI / UDI-DI
00850013050130 FDA UDI
510(k) Number
K983463 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
General/multiple surgical diode/carbon dioxide laser system 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: General/multiple surgical diode/carbon dioxide laser system

SureBlade by Clinicon Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General/multiple surgical diode/carbon dioxide laser system.

Cleared under the same submission

K983463 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Clinicon Corp.

Sources (1)

  • FDA UDI 88401fdb-bab9-4f17-90c2-e52841d4ea52 34 fields · synced May 29, 2026