Skip to content

Prolong, Models Pl 18040TC, PL18050TGC, PL18100TGC, PL18150TGC,

by Life-Tech, Inc.

510(k) K102007

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 · Special NumberK102007 Date22 Dec 2010ClearedStatusActive

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  • Withdrawn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
CAZ
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 868.5140
Advisory Committee
Anesthesiology
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.

The Prolong Continuous Nerve Block Set is an Anesthesia Conduction Kit, designed for the administration of anesthesia and analgesia through peripheral nerve blockade. It provides a continuous infusion system for sustained nerve conduction, facilitating prolonged pain management and anesthetic effects during surgical or diagnostic procedures.

This single-use, sterile device is intended for use in clinical settings by trained healthcare professionals, including anesthesiologists. Supplied in sterile packaging, the set includes models with varying configurations (PL 18040TC, PL18050TGC, PL18100TGC, PL18150TGC) for compatibility with different nerve block applications. The device holds FDA 510(k) clearance (K102007) under the Anesthesiology advisory committee and is classified as a Class II medical device under regulation number 868.5140.

Other devices from Life-Tech Intl., Inc.

See all devices from Life-Tech Intl., Inc. →