FDA.reportPublic FDA data

AnchorKnot Tissue Approximation Kit

Primary DI
07540299000150
Brand
AnchorKnot Tissue Approximation Kit
Company
Baylis Medical Technologies Inc
Model
PSZ-400-312
Device description
AnchorKnot Suture Passer (2-0); AnchorKnot Knot Pusher (2-0); AnchorKnot Suture Cutter (2-0)
Published
2022-11-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161878000PORTAGE SystemBaylis Medical Company, Inc.2016-09-26HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00685447001768PreviousGS10
07540299000150PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00685447001768006854470017686854470017680685447001768
07540299000150075402990001507540299000150

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic surgical procedure kit, non-medicated, single-useA collection of various sterile surgical and endoscopic instruments, dressings, and additional materials intended to be used specifically to perform an arthroscopic surgical procedure. It does not contain any pharmaceuticals. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
240389677
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540299000426PowerWire 14 Radiofrequency Guidewire KitPW14-190-S2025-12-04
07540299000433PowerWire 14 Radiofrequency Guidewire KitPW14-300-S2025-12-04
07540299000471PowerWire 14 Radiofrequency Guidewire KitPW14-190-20A2025-12-04
07540299000488PowerWire 14 Radiofrequency Guidewire KitPW14-300-20A2025-12-04
07540299000440 PowerWire Pulse RF Guidewire KitPTK35-250-08-6S2024-09-27
07540299000457 PowerWire Pulse RF Guidewire KitPTK35-250-10-6S2024-09-27
07540299000464 PowerWire Pulse RF Guidewire KitPTK35-250-12-6S2024-09-27
07540299000020AnchorKnot SutureASU-0-W-CL2022-11-16
07540299000037AnchorKnot SutureASU-2-0-WB-CL2022-11-16
07540299000044AnchorKnot SutureASU-2-0-W-CL2022-11-16
07540299000051AnchorKnot SutureASU-2-WB-CL2022-11-16
07540299000068AnchorKnot SutureASU-2-W-CL2022-11-16
07540299000013AnchorKnot SutureASU-0-WB-CL2022-11-16
07540299000075AnchorKnot SutureASU-0-WB-LR2022-11-16
07540299000082AnchorKnot SutureASU-0-W-LR2022-11-16
07540299000099AnchorKnot SutureASU-2-0-WB-LR2022-11-16
07540299000105AnchorKnot SutureASU-2-0-W-LR2022-11-16
07540299000112AnchorKnot SutureASU-2-WB-LR2022-11-16
07540299000129AnchorKnot SutureASU-2-W-LR2022-11-16
07540299000136AnchorKnot Suture Passer (2-0) PSZ-400-3052022-11-16

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