FDA.reportPublic FDA data

XLEND23MULTIFLEX

Primary DI
00840096215304
Brand
XLEND23MULTIFLEX
Company
KATALYST SURGICAL LLC
Model
XLEND23MULTIFLEX
Catalog number
XLEND23MULTIFLEX
Device description
23ga MultiFlex Laser Probe, Quantel Compatible
Published
2025-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HQBPhotocoagulator And Accessories
HQFLaser, Ophthalmic
MPAEndoilluminator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HQBPhotocoagulator And AccessoriesOphthalmic2
HQFLaser, OphthalmicOphthalmic2
MPAEndoilluminatorGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121187000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121187000KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBESKatalyst Surgical, LLC2012-09-17HQF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840096215301PackageGS110In Commercial Distribution
00840096215304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084009621530110840096215301
00840096215304008400962153048400962153040840096215304

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic laser system beam guideA sterile, hand-held, probe-like device intended to be used in conjunction with an ophthalmic laser system during ophthalmic surgery to invasively direct and deliver laser energy to treat non-refractive conditions (e.g., to repair a retinal tear). It consists of a fibreoptic cable, a handpiece, and a distal invasive cannula/probe which may be available in a variety of configurations (e.g., bent or straight); it may be capable of further functionality (e.g., aspiration, illumination). This is a single-use device.

Regulatory Flags#

DUNS number
007883297
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840096215380Disposable Bipolar Forceps, 8", 1.5mm Straight TipsDNK8-15SDNK8-15S2026-10-08
0081748902541323ga DEX™ Morris ILM ForcepsDVF4033-23DVF4033-232026-10-07
0084009620260127ga DEX™ Yoneda Super Grip ForcepsDVF4036-27DVF4036-272026-10-07
0084009620360823ga DEX™ Yoneda Super Grip ForcepsDVF4036-23DVF4036-232026-10-07
0084009620361525ga DEX™ Yoneda Super Grip ForcepsDVF4036-25DVF4036-252026-10-07
0084009620509125ga DEX Stiff NanoTapered Awh ForcepsDVF4005-25-SDVF4005-25-S2026-10-07
0084009620510725ga DEX Stiff Morris Honey Badger ForcepsDVF4010-25-SDVF4010-25-S2026-10-07
0084009620511425ga DEX Stiff Asymmetrical Tano ForcepsDVF4014-25-SDVF4014-25-S2026-10-07
0084009620512125ga (0.50mm) Dex™ Stiff Serrated Jaw ForcepsDVF4016-25-SDVF4016-25-S2026-10-07
0084009620513825ga DEX Stiff Maculorhexis ForcepsDVF4019-25-SDVF4019-25-S2026-10-07
0084009620514525ga DEX Stiff End Grasper ForcepsDVF4022-25-SDVF4022-25-S2026-10-07
0084009620515225ga DEX Stiff Morris ILM ForcepsDVF4033-25-SDVF4033-25-S2026-10-07
0084009620516925ga DEX™ Stiff Super Grip ForcepsDVF4034-25-SDVF4034-25-S2026-10-07
0084009620518325ga DEX Stiff Curved Horizontal ScissorsDVS5006-25-SDVS5006-25-S2026-10-07
0084009620519025ga DEX Stiff Vertical ScissorsDVS5101-25-SDVS5101-25-S2026-10-07
00840096215335Disposable Bipolar Forceps, 7", 0.5mm Straight TipsDNK7-05SDNK7-05S2026-10-07
00840096215342Disposable Bipolar Forceps, 7", 1.0mm Straight TipsDNK7-10SDNK7-10S2026-10-07
00840096215359Disposable Bipolar Forceps, 7", 1.5mm Straight TipsDNK7-15SDNK7-15S2026-10-07
00840096215366Disposable Bipolar Forceps, 8", 0.5mm Straight TipsDNK8-05SDNK8-05S2026-10-07
00840096215373Disposable Bipolar Forceps, 8", 1.0mm Straight TipsDNK8-10SDNK8-10S2026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840096211075Illuminated Laser Probe, OS4, StraightKATALYST SURGICAL LLCHQF2023-06-07
1084009621395625ga Illuminated MultiFlex™ Laser Probe, DORC ConnectorKATALYST SURGICAL LLCMPA2021-01-07
1084009621334527ga Stiff MultiFlex Inverted Extendable Laser Probe, Iridex ConnectorKATALYST SURGICAL LLCHQF2020-10-27
1084009621335227ga Stiff MultiFlex Inverted Extendable Laser Probe, Alcon ConnectorKATALYST SURGICAL LLCHQF2020-10-27
1084009621336927ga Stiff MultiFlex Inverted Extendable Laser Probe, Quantel ConnectorKATALYST SURGICAL LLCHQF2020-10-27
1084009621337627ga Stiff MultiFlex Inverted Extendable Laser Probe, Nidek ConnectorKATALYST SURGICAL LLCHQF2020-10-27
1084009621338327ga Stiff MultiFlex Inverted Extendable Laser Probe, Dorc ConnectorKATALYST SURGICAL LLCHQF2020-10-27
00840096208283Constellation Illumination AdapterKATALYST SURGICAL LLCMPA2020-06-10
00840096208290Stellaris Illumination AdapterKATALYST SURGICAL LLCMPA2020-06-10
00840096208306DORC Illumination AdapterKATALYST SURGICAL LLCMPA2020-06-10
00840096208313Short 19ga Needle Illumination AdapterKATALYST SURGICAL LLCMPA2020-06-10
00840096208276Revolver Universal ConnectorKATALYST SURGICAL LLCMPA2020-06-08
1084009621123520ga Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621124223ga Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621125925ga Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621126627ga Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621127323ga Flexible Curved Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621128025ga Flexible Curved Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621129727ga Flexible Curved Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621130320ga Illuminated Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621131023ga Illuminated Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621132725ga Illuminated Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621133427ga Illuminated Straight Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621134123ga Illuminated Flexible Curved Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
1084009621135825ga Illuminated Flexible Curved Laser ProbeKATALYST SURGICAL LLCHQF2020-03-04
10817489024536Revolver FiberKATALYST SURGICAL LLCHQF2019-07-17
1081748902767425ga Stiff Illuminated MultiFlex™ Laser Probe, Iridex ConnectorKATALYST SURGICAL LLCHQF2019-04-03
1081748902767425ga Stiff Illuminated MultiFlex™ Laser Probe, Iridex ConnectorKATALYST SURGICAL LLCMPA2019-04-03
1081748902767425ga Stiff Illuminated MultiFlex™ Laser Probe, Iridex ConnectorKATALYST SURGICAL LLCHQB2019-04-03
1081748902768127ga Stiff Illuminated MultiFlex™ Laser Probe, Iridex ConnectorKATALYST SURGICAL LLCHQF2019-04-03