FDA 510(k)

Monocryl Plus Antibacterial Suture

K-번호: K201996 · 2020-12-21

결정일2020-12-21

제품 코드GAM

자문 위원회SU

결정Substantially Equivalent

기기 요약

Monocryl Plus Antibacterial Suture is the device name listed in this FDA 510(k) record. The listed applicant is ETHICON, Inc.. It received FDA 510(k) clearance on 2020-12-21 under 510(k) number K201996. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Monocryl Plus Antibacterial Suture?

Monocryl Plus Antibacterial Suture is a medical device that received FDA 510(k) clearance on 2020-12-21. The listed applicant is ETHICON, Inc.. The 510(k) number is K201996.

When did Monocryl Plus Antibacterial Suture receive FDA 510(k) clearance?

Monocryl Plus Antibacterial Suture received FDA 510(k) clearance on 2020-12-21, under 510(k) number K201996.

Who is the listed applicant for Monocryl Plus Antibacterial Suture?

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

What is the FDA product code for Monocryl Plus Antibacterial Suture?

The FDA product code for Monocryl Plus Antibacterial Suture is GAM.

ETHICON, Inc.를 신청인으로 등재한 기타 기록

K253394Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device K253852MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture K252743STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device K243897PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture

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