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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 a medical device manufactured by Stryker Endoscopy. It received FDA 510(k) clearance on 2023-08-30 under approval 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. It is manufactured by Stryker Endoscopy. The 510(k) number is K231093.

When was AlphaVent Suture Anchors approved by the FDA?

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

What company makes AlphaVent Suture Anchors?

AlphaVent Suture Anchors is manufactured by Stryker Endoscopy.

What is the FDA product code for AlphaVent Suture Anchors?

The FDA product code for AlphaVent Suture Anchors is MBI.

Related Clinical Trials

NCT04552119 Safety of Treatment of Shoulder Repair COMPLETED NCT06272201 Incisionless Suture Plications in a POSE2.0 Obesity Study NOT_YET_RECRUITING

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Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

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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