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FDA 510(k)

Button Loop

K-Number: K202291 · 2021-01-08

ApplicantYunyi (Beijing) Medical Device Co., Ltd.
Decision Date2021-01-08
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Button Loop is the device name listed in this FDA 510(k) record. The listed applicant is Yunyi (Beijing) Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2021-01-08 under 510(k) number K202291. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Button Loop?

Button Loop is a medical device that received FDA 510(k) clearance on 2021-01-08. The listed applicant is Yunyi (Beijing) Medical Device Co., Ltd.. The 510(k) number is K202291.

When did Button Loop receive FDA 510(k) clearance?

Button Loop received FDA 510(k) clearance on 2021-01-08, under 510(k) number K202291.

Who is the listed applicant for Button Loop?

The FDA 510(k) record lists Yunyi (Beijing) Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Button Loop?

The FDA product code for Button Loop is MBI.

Other records listing Yunyi (Beijing) Medical Device 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.

K192637High Strength Suture

Related Devices (Code: MBI)

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.

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

Official Source

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

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