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Staples Designed for Arthroscopic Surg

by Instrument Makar, Inc.

510(k) K830455

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 NumberK830455 Date9 Mar 1983ClearedStatusActive

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  • Withdrawn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
JDR
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

Staples Designed for Arthroscopic Surg are medical devices used in arthroscopic surgery. They are intended for use in orthopedic procedures.

These staples are supplied as single-use devices. They are sterile and require proper storage conditions. The device is regulated under FDA 510(k) clearance K830455.

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Questions

AI-generated answers, 25 Sep 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 these staples used for?

    These staples are designed for use in arthroscopic surgery, specifically for orthopedic procedures.

  • Are these staples sterile?

    Yes, the staples are supplied as sterile devices.

  • Is this a single-use device?

    Yes, the staples are intended for single-use and should not be reused.

  • How is this device regulated?

    This device is regulated under FDA 510(k) clearance with the number K830455.