FDA 510(k)

Monodek® (POLYDIOXANONE) 染成紫罗兰色的单丝合成可吸收外科缝合线

K号: K261988 · 2026-07-09

决定日期2026-07-09

产品代码NEW

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决定实质等同

器械摘要

Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture is the device name listed in this FDA 510(k) record. The listed applicant is Teleflex Medical, LLC. It received FDA 510(k) clearance on 2026-07-09 under 510(k) number K261988. The device is classified under product code NEW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture?

Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture is a medical device that received FDA 510(k) clearance on 2026-07-09. The listed applicant is Teleflex Medical, LLC. The 510(k) number is K261988.

When did Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture receive FDA 510(k) clearance?

Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture received FDA 510(k) clearance on 2026-07-09, under 510(k) number K261988.

Who is the listed applicant for Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture?

The FDA 510(k) record lists Teleflex Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture?

The FDA product code for Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical Suture is NEW.

列明Teleflex Medical, LLC为申报人的其他记录

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