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Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors

by Responsive Arthroscopy, LLC

510(k) K230094

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK230094 Date25 Aug 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MBI
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors are soft tissue fixation fasteners designed for the attachment of soft tissue to bone. These anchoring systems are indicated for use in procedures involving the shoulder and foot or ankle.

This device is classified as a nondegradable soft tissue fixation fastener under product code MBI. It has received FDA 510(k) clearance under K230094.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the Stealth and Mini Stealth All-Suture Anchors used for?

    The Stealth and Mini Stealth All-Suture Anchors are designed for the attachment of soft tissue to bone. They are specifically indicated for use in surgical procedures involving the shoulder, foot, or ankle.

  • What is the regulatory status of these anchors?

    These devices are classified as nondegradable soft tissue fixation fasteners. They have received FDA 510(k) clearance under K230094, confirming they are substantially equivalent to existing devices for their intended use.

  • How are these anchors classified for clinical use?

    The anchors are categorized under product code MBI, which identifies them as nondegradable soft tissue fixation fasteners. This classification is part of the orthopedic device category reviewed by the FDA.