FDA.reportPublic FDA data

AnchorKnot Suture Passer (2-0)

Primary DI
07540299000136
Brand
AnchorKnot Suture Passer (2-0)
Company
Baylis Medical Technologies Inc
Model
PSZ-400-305
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

Contact Domains#

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
00685447001744PreviousGS10
07540299000136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00685447001744006854470017446854470017440685447001744
07540299000136075402990001367540299000136

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, single-useA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure; it may also knot, cut and/or tighten the sutures/ligature loop during or after placement. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
905-948-5800info@baylismedtech.com

Regulatory Flags#

DUNS number
240389677
Device count
1
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
07540299000143AnchorKnot Knot Pusher (2-0) and Suture Cutter (2-0) PSZ-400-3112022-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250337121015Combo Optic AdapterJoimax GmbHHRX2026-10-19
08058964729767Easy Winch 13 G, 15 mmG21 SRLHRX2026-10-19
08058964729774Easy Winch 13 G, 10 mmG21 SRLHRX2026-10-19
08058964728692Winch Kyphoplasty Balloon Catheter 15G 10 mmG21 SRLHRX2026-09-30
08058964728708Winch Kyphoplasty Balloon Catheter 15G 15 mmG21 SRLHRX2026-09-30
04066524011683Arthroscope Ø 2.7 mm, 0°, 140 mm, autoclavableXION GmbHHRX2026-09-25
04066524011690Arthroscope Ø 2.7 mm, 30°, 140 mm, autoclavableXION GmbHHRX2026-09-25
04066524011706Arthroscope Ø 2.7 mm, 70°, 140 mm, autoclavableXION GmbHHRX2026-09-25
04066524011713HD3 Arthroscope Ø 4 mm, 0°,185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011720HD3 Arthroscope Ø 4 mm, 30°, 185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011737HD3 Arthroscope Ø 4 mm, 45°, 185 mm, autoclavableXION GmbHHRX2026-09-25
04066524011744HD3 Arthroscope Ø 4 mm, 70°, 185 mm, autoclavableXION GmbHHRX2026-09-25
08809695579813Trocar Needle (Working Channel)GS Medical Co., Ltd.HRX2026-07-27
08809695579820Bevel Needle (Working Channel)GS Medical Co., Ltd.HRX2026-07-27
00190776422059MillenniumAvalign Technologies, Inc.HRX2026-07-24
00190776422066MillenniumAvalign Technologies, Inc.HRX2026-07-24
10810004821085Spinal Needle SetCLARUS MEDICAL, LLCHRX2026-06-23
10810004821146Curved Cannula SetCLARUS MEDICAL, LLCHRX2026-06-23
00810004821101Digital SpineScope EndoscopeCLARUS MEDICAL, LLCHRX2026-06-22
10810004821122Spinal Introducer SetCLARUS MEDICAL, LLCHRX2026-06-22
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCHRX2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCHRX2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCHRX2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCHRX2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCHRX2026-06-03
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-02
00846338005146Neutral PlateELLIQUENCE, LLCHRX2026-06-01