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Needle Set, a-V Fistula

by Medical Disposables Intl., Inc.

510(k) K770699

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 NumberK770699 Date14 Jun 1977ClearedStatusActive

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  • Withdrawn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
FIE
Device Class
Class II
Regulation
21 CFR Part 876.5540
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

This device is a Needle Set, AV Fistula, designed for accessing arteriovenous fistulas in medical procedures. It consists of twin needles with fixed wings, intended for reliable vascular access in hemodialysis or other clinical applications requiring repeated punctures.

The set is supplied as a sterile, single-use device, packaged in a twin configuration with 17-gauge needles measuring 1" in length. It includes an anti-stick needle protector (MasterGuard Plus) to reduce friction and improve safety. Regulated under FDA 510(k) clearance (K770699), it adheres to Class II medical device standards for vascular access tools.

Other devices from Medical Disposables Intl., Inc.

Questions

AI-generated answers, 19 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 is the primary use of this needle set in clinical settings?

    This needle set is specifically designed for accessing arteriovenous (AV) fistulas, which are surgically created connections between an artery and a vein. It is commonly used in hemodialysis procedures or other clinical applications requiring repeated vascular access, ensuring reliable puncture of the fistula for fluid exchange or monitoring.

  • Are the needles in this set reusable, or are they intended for single-use only?

    The needle set is explicitly labeled as a sterile, single-use device. Reuse is not recommended or supported, as it could compromise patient safety and sterility, leading to potential infections or complications.

  • What safety features does this needle set include to reduce patient risk during use?

    This needle set includes an anti-stick needle protector (MasterGuard Plus), which reduces friction and improves safety by minimizing the risk of needle stick injuries during insertion or removal. This feature also helps prevent accidental punctures after use.

  • How are the needles packaged, and what gauge and length should I expect?

    The needle set is supplied in a twin configuration, meaning it comes with two needles pre-packaged together. Each needle is 17-gauge and measures 1 inch (1”) in length, designed for precise and stable access to AV fistulas.

  • What regulatory pathway does this device follow, and what does that mean for its use?

    This needle set was cleared through the FDA’s 510(k) process under the classification of a Class II medical device, meaning it has undergone review to demonstrate substantial equivalence to a legally marketed predicate device. This clearance ensures it meets established safety and performance standards for vascular access tools, but it does not imply any specific clinical indication beyond its labeled use for AV fistula access.