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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 the device name listed in this FDA 510(k) record. The listed applicant is Kono Seisakusho Co., Ltd.. It received FDA 510(k) clearance on 2020-05-29 under 510(k) 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. The listed applicant is Kono Seisakusho Co., Ltd.. The 510(k) number is K192420.

When did Crownjun Nylon Suture receive FDA 510(k) clearance?

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

Who is the listed applicant for Crownjun Nylon Suture?

The FDA 510(k) record lists Kono Seisakusho Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Crownjun Nylon Suture?

The FDA product code for Crownjun Nylon Suture is GAR.

Other records listing Kono Seisakusho Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230281PICOCLAMP

Related Devices (Code: GAR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261484Tissue Approximation SystemTas Medical, Inc.K220980Tissue Approximation System (TAS)Tas Medical, Inc.K212888Golnit Nylon Monofilament SutureAntarma, LLC Dba Golnit SuturesK212603Non Absorbable Surgical Nylon SutureShandong Haidike Medical Product Co., Ltd.K161633REXLON, REXSILSm Eng Co., Ltd.K151165Aesculap Dafilon Nonabsorbable Polyamide Surgical SutureAesculap, 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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