Teleflex Medical LLC

FDA Device Registration & Listing · MANSFIELD, MA, US · Registration 1221601

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1221601
FEI Number
1221601
Entity Name
Teleflex Medical LLC
City/State/Country
MANSFIELD, MA, US
Establishment Address
375 FORBES BLVD., MANSFIELD, MA 02048, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Teleflex (Owner Number: 9062981)
Owner / Operator Contact Address
3015 Carrington Mill Blvd., Morrisville, NC 27560, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K162396
PMA Number
N/A

All Registered Proprietary Names

NEXTSTITCH POLYETHYLENE SYNTHETIC NONABSORBABL Cottony II, Silky II Polydek Tevdek II MONODEK POLYSORB SYNTHETIC ABSORBABLE SUTUR Force Fiber SAPH IOOP APH IOOP NEXTSTITCH POLYETHYLENE SYNTHETIC NONABSORBABL DEKNATEL SAPHLOOP BONDEK BONDEK SYNTHETIC ABSO Force Fiber Deknatel®, Deklene®, Deklene® Maxx™, Capio DEKNATEL Polydek Deklene Tevdek Deklene Maxx Cottony BONDEK Deknatel MULTIPLE POLYAMIDE SYNTH SAPH IOOP POLYETHYLENE SYNTHETIC NONABSORBABL E SUTURES APH IOOP NEXTSTITCH DEKNATEL Force Fiber OrthoTape Tevdek COTTONY II, Silky II, Polydek, DEKNATEL Tevdek II DEKNATEL Cottony MULTIPLE SURGICAL INSTRUMENT GUIDES DEKNATEL PILLING Force Fiber Paratrooper Plantar Plate Repair System Force Fiber Force Fiber® Suture Force Fiber Bondek Monodek MULTIPLE STERILE ABSORABLE SUTURES Deklene DEKNATEL OPTHAMEND Force Fiber Deknatel®, Tevdek®, Capio, LSI, Niceloop, Polydek®, NextStich®, silky, Cottony DEKNATEL

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2005-12-20
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2005-09-13
GAN Suture, Absorbable, Synthetic General, Plastic Surgery Class 2 878.4830 2009-10-09
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2011-06-15
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2002-12-13
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2005-12-20
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2011-06-15
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2020-04-17
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile General, Plastic Surgery Class 2 878.4495 2016-11-03
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 2016-11-03
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2016-11-03
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2016-11-03
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2016-11-03
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2005-12-20
OVN Suture Kit General, Plastic Surgery Class 2 878.4830 2011-10-25
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 1992-08-03
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2005-12-20
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2015-04-10
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2008-09-16
GAO Suture, Nonabsorbable General, Plastic Surgery Class 2 878.4495 2016-11-03
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2016-11-03
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2016-11-03
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 2016-11-03
GAS Suture, Nonabsorbable, Synthetic, Polyester General, Plastic Surgery Class 2 878.5000 2016-11-03
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile General, Plastic Surgery Class 2 878.4495 2016-11-03
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene Cardiovascular Class 2 870.3470 2016-11-03
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 2016-11-03
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 1995-10-02
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2008-03-11
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-06-17
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2024-06-17
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2008-03-11
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-11-30
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 2019-01-28
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2019-01-28
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2019-01-28
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 1992-08-03
GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile General, Plastic Surgery Class 2 878.4495 1992-08-03
GAR Suture, Nonabsorbable, Synthetic, Polyamide General, Plastic Surgery Class 2 878.5020 1992-08-03
GAL Suture, Absorbable, Natural General, Plastic Surgery Class 2 878.4830 1992-08-03
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 1992-08-03
GAM Suture, Absorbable, Synthetic, Polyglycolic Acid General, Plastic Surgery Class 2 878.4493 1992-08-03
GAW Suture, Nonabsorbable, Synthetic, Polypropylene General, Plastic Surgery Class 2 878.5010 1992-08-03
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2008-03-11
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2020-04-17
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2016-11-23

Official Correspondent

Divya Raman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Teleflex
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013515223 T.K. India Pvt. Ltd. Chandigarh, IN
3004365956 Teleflex Medical de Mexico, S. de R.L. de C.V. NUEVO LAREDO Tamaulipas, MX
3010041511 Teleflex LLC (NADC) Olive Branch, MS, US
3007134520 TELEFLEX MEDICAL ATHLONE Westmeath, IE
8040412 Teleflex Medical Sdn. Bhd. KAMUNTING Perak, MY

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K072322 Smith & Nephew, Inc. ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS 2007-09-18
K123940 Demetech Corp. DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE 2014-05-30
K050845 ETHICON, Inc. MONOCRYL PLUS ANTIBACTERIAL SUTURE 2005-06-29
K241486 Covidien Sofsilk™ Coated Braided Silk Suture 2024-12-03
K193295 Parcus Medical, LLC Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor 2020-01-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0010-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0011-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0012-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0013-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0014-2021 Riverpoint Medical, LLC 2
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 20884521151403 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1221601. Last updated year: 2026. Please use registration number 1221601 when referencing this establishment in official correspondence.
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