FDA.reportPublic FDA data

SureGuide

Primary DI
00850013050178
Brand
SureGuide
Company
Clinicon Corporation
Model
3156
Device description
SureGuide, 2.75m Fiber Cable Assembly,SMA with Interlock Wire
Published
2021-05-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992472000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992472000SUREGUIDE CO2 LASER BEAM DELIVERY SYSTEMClinicon Corp.1999-09-08GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850013050178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013050178008500130501788500130501780850013050178

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, single-useA surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
785275777
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850013050154SureGuide40342021-05-06
00850013050161SureGuide41402021-05-06
00850013050185SureGuide41432021-05-06
00850013050000SureProbe40002021-05-05
00850013050017SureProbe40012021-05-05
00850013050024SureProbe40022021-05-05
00850013050031SureProbe40072021-05-05
00850013050048SureProbe40032021-05-05
00850013050055SureProbe40082021-05-05
00850013050062SureProbe40042021-05-05
00850013050079SureProbe41592021-05-05
00850013050086SureProbe41492021-05-05
00850013050093SureProbe40112021-05-05
00850013050116SureTouch40122021-05-05
00850013050123SureTip37282021-05-05
00850013050130SureBlade25722021-05-05
00850013050147SureBlade29862021-05-05
00850013050192SureScan35662021-05-05
00850013050208Luxar41512021-05-05
00850013050215SureLase40602021-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00075020120335Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
00075020120410Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08059173390243Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390274Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390304Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390335Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390366Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07
08059173390069Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390076Twain EvoQUANTA SYSTEM SPAGEX2018-12-14
08059173390083Twain EvoQUANTA SYSTEM SPAGEX2018-12-14