FDA.reportPublic FDA data

COR-KNOT MICRO™

Primary DI
10850200006930
Brand
COR-KNOT MICRO™
Company
LSI Solutions, Inc.
Model
032500
Catalog number
032500
Device description
COR-KNOT MICRO™ DEVICE Pre-Loaded with (1) titanium COR-KNOT MICRO™ FASTENER
Published
2021-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202551000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202551000Cor-Knot MicroLsi Solutions, Inc.2021-06-24GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850200006930PackageGS16In Commercial Distribution
00850200006933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085020000693010850200006930
00850200006933008502000069338502000069330850200006933

GMDN Terms#

Term, Definition table
TermDefinition
Suture clasp, non-bioabsorbableA small, sterile, implantable fastening device designed to secure the ends of a suture as an alternative to tying a knot, for approximation of soft tissue and/or prosthetic materials during a surgical procedure. It is made of non-bioabsorbable materials [e.g., titanium (Ti)] and is typically implanted with a dedicated applicator.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14Centimeter
Outer Diameter3Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)575-3493regulatorydpt@lsisolutions.com

Regulatory Flags#

DUNS number
603420183
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850012846741JNW URTRAC0813000813002026-08-21
00850012846710ValveVault0820650820652026-07-08
00850012846703PicoDriver0234700234702026-04-28
00850012846246MD™ QUICK LOAD®0231600231602022-12-22
00850012846529RD® QUICK LOAD®0233870233872025-07-09
00850012846543RAM® COR-SUTURE® QUICK LOAD®0234070234072025-07-28
00850200006148RD® QUICK LOAD®0209790209792015-12-04
00850200006346COR-SUTURE® QUICK LOAD®0218610218612016-05-12
00850200006353COR-SUTURE® QUICK LOAD®0218620218622016-05-12
00850200006407RAM® COR-SUTURE® QUICK LOAD®0220900220902018-06-02
00850200006438RAM® COR-SUTURE® QUICK LOAD®0220470220472018-06-02
00850200006445RAM® COR-SUTURE® QUICK LOAD®0220390220392020-03-13
00850200006452RAM® COR-SUTURE® QUICK LOAD®0223350223352020-03-13
00850200006469RAM® COR-SUTURE® QUICK LOAD®0223200223202020-03-13
00850200006476RAM® COR-SUTURE® QUICK LOAD®0223250223252020-03-13
00850200006483RAM® COR-SUTURE® QUICK LOAD®0223400223402020-03-13
00850200006766RAM® COR-SUTURE® QUICK LOAD®0226680226682020-03-13
00850200006773RAM® COR-SUTURE® QUICK LOAD®0226710226712020-03-13
00850200006780RAM® COR-SUTURE® QUICK LOAD®0226740226742020-03-13
00850200006797RAM® COR-SUTURE® QUICK LOAD®0226800226802020-03-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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