Atlas FDA

Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture

FDA 510(k) clearance K261988 · decided 2026-07-09

Clearance details

K-number
K261988
Device name
Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture
Applicant
Teleflex Medical, LLC
Decision
Substantially Equivalent
Date received
2026-06-12
Decision date
2026-07-09
Days to decision
27 days
Clearance type
Special
Product code
NEW
Device class
2
Regulation number
878.4840
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Morrisville, NC, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Barbed PDO Suture (K252171)Sutura Medical Technology, Inc.2026-06-12
STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices (K252047)ETHICON, Inc.2026-05-18
PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture (K243897)ETHICON, Inc.2025-11-12
Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) (K251414)Feeltech Co., Ltd.2025-10-20
V-soft Line™ Barbed Surgical Suture (Various) (K250107)Feeltech Co., Ltd.2025-10-15
PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; PINION™ PGA-PCL Knotless Suture - Absorbable Poly (Glycolide-Co-Caprolactone) Knotless Suture (K252644)M/s. Meril Endo Surgery Private Limited.2025-09-23
Suture-TOOL System (K250977)Suturion AB2025-04-28
Suture-TOOL System (K242835)Suturion AB2025-01-22
Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938 (K242571)Hyundae Meditech Co., Ltd.2024-09-27
1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION™ PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture (K232246)M/s. Meril Endo Surgery Private Limited.2024-04-25
Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150) (K240389)Hyundae Meditech Co., Ltd.2024-03-27
MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 (K220549)Hans Biomed Corporation2023-03-07

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
MANTA™ Vascular Closure Device; MANTA Vascular Closure Device, 18F; MANTA Vascular Closure Device, 14F; MANTA SF Depth L (P180025/S014)Teleflex Medical, LLC2025-08-05
MANTA™ Vascular Closure Device (P180025/S013)Teleflex Medical, LLC2025-01-03
MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator (P180025/S012)Teleflex Medical, LLC2024-06-07
MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator (P180025/S011)Teleflex Medical, LLC2024-03-06
MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator (P180025/S010)Teleflex Medical, LLC2023-10-11
MANTA Vascular Closure Device (P180025/S009)Teleflex Medical, LLC2021-04-19
MANTA Vascular Closure Device (P180025/S008)Teleflex Medical, LLC2020-09-18
MANTA Vascular Closure Device (P180025/S007)Teleflex Medical, LLC2020-05-26