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FDA 510(k)

Crownjun Nylon Suture

K-Number: K192420 · 2020-05-29

ApplicantKono Seisakusho Co., Ltd.
Decision Date2020-05-29
Product CodeGAR
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Crownjun Nylon Suture is a medical device manufactured by Kono Seisakusho Co., Ltd.. It received FDA 510(k) clearance on 2020-05-29 under approval number K192420. The device is classified under product code GAR. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Crownjun Nylon Suture?

Crownjun Nylon Suture is a medical device that received FDA 510(k) clearance on 2020-05-29. It is manufactured by Kono Seisakusho Co., Ltd.. The 510(k) number is K192420.

When was Crownjun Nylon Suture approved by the FDA?

Crownjun Nylon Suture received FDA 510(k) clearance on 2020-05-29, under approval number K192420.

What company makes Crownjun Nylon Suture?

Crownjun Nylon Suture is manufactured by Kono Seisakusho Co., Ltd..

What is the FDA product code for Crownjun Nylon Suture?

The FDA product code for Crownjun Nylon Suture is GAR.

Other Devices by Kono Seisakusho Co., Ltd.

K230281PICOCLAMP

Related Devices (Code: GAR)

K151165Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureAesculap, Inc. K161633REXLON, REXSILSm Eng Co., Ltd. K212603Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd. K212888Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit Sutures K220980Tissue Approximation System (TAS)Tas Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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