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FDA 510(k)

Stryker ProCinch Adjustable Loop Device

K-Number: K210078 · 2021-03-11

ApplicantStryker Endoscopy
Decision Date2021-03-11
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Stryker ProCinch Adjustable Loop Device is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2021-03-11 under 510(k) number K210078. 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 Stryker ProCinch Adjustable Loop Device?

Stryker ProCinch Adjustable Loop Device is a medical device that received FDA 510(k) clearance on 2021-03-11. The listed applicant is Stryker Endoscopy. The 510(k) number is K210078.

When did Stryker ProCinch Adjustable Loop Device receive FDA 510(k) clearance?

Stryker ProCinch Adjustable Loop Device received FDA 510(k) clearance on 2021-03-11, under 510(k) number K210078.

Who is the listed applicant for Stryker ProCinch Adjustable Loop Device?

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

What is the FDA product code for Stryker ProCinch Adjustable Loop Device?

The FDA product code for Stryker ProCinch Adjustable Loop Device is MBI.

Related Clinical Trials

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.

NCT07631468PROspect Registry :Post Market Clinical Follow-up StudyRECRUITING

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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

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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