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Sureloc Circuit Connector

by Polamedco, Inc.

510(k) K954383

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

Overview

A comprehensive medical device directory listing the Sureloc Circuit Connector, a widely used connector for airway extension in anesthesia practice. This device has undergone substantial equivalent evaluation and is certified as meeting or exceeding regulatory requirements.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK954383 Date22 Dec 1995ClearedStatusActive

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  • Withdrawn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
BZA
Device Class
Class I
Regulation
21 CFR Part 868.5810
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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