Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors

K-Number: K230094 · 2023-08-25

ApplicantResponsive Arthroscopy, LLC
Decision Date2023-08-25
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors is the device name listed in this FDA 510(k) record. The listed applicant is Responsive Arthroscopy, LLC. It received FDA 510(k) clearance on 2023-08-25 under 510(k) number K230094. 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 Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors?

Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors is a medical device that received FDA 510(k) clearance on 2023-08-25. The listed applicant is Responsive Arthroscopy, LLC. The 510(k) number is K230094.

When did Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors receive FDA 510(k) clearance?

Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors received FDA 510(k) clearance on 2023-08-25, under 510(k) number K230094.

Who is the listed applicant for Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors?

The FDA 510(k) record lists Responsive Arthroscopy, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors?

The FDA product code for Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors is MBI.

Other records listing Responsive Arthroscopy, LLC 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.

K261632Thunderbolt SystemK253010Mini Superhawk Suture Anchor SystemK243726Osprey Suture AnchorK233258Shadow Knotless All-Suture AnchorsK222763Responsive Arthroscopy Mustang and Mustang Knotless Suture AnchorsK203121Responsive Arthroscopy Thunderbolt System

View all 13 devices →

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.

↑