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FDA 510(k)

AlphaVent Suture Anchors

K-Number: K231093 · 2023-08-30

ApplicantStryker Endoscopy
Decision Date2023-08-30
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AlphaVent Suture Anchors is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 2023-08-30 under 510(k) number K231093. 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 AlphaVent Suture Anchors?

AlphaVent Suture Anchors is a medical device that received FDA 510(k) clearance on 2023-08-30. The listed applicant is Stryker Endoscopy. The 510(k) number is K231093.

When did AlphaVent Suture Anchors receive FDA 510(k) clearance?

AlphaVent Suture Anchors received FDA 510(k) clearance on 2023-08-30, under 510(k) number K231093.

Who is the listed applicant for AlphaVent Suture Anchors?

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 AlphaVent Suture Anchors?

The FDA product code for AlphaVent Suture Anchors 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

Other records listing Stryker Endoscopy 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.

K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownK253602Precision S 4K SinuscopeK261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemK2601851688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging ModalityK260108L12 LED Light Source with AIMK254014Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control

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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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