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Vital 5 ReLeaf Catheter

by Vital 5

510(k) K122661

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 NumberK122661 Date27 Feb 2013ClearedStatusActive

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  • Withdrawn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
BSO
Device Class
Class II
Regulation
21 CFR Part 868.5120
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 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 Vital 5 ReLeaf Catheter is a Class 2 device with product code BSO, designed as a conduction anesthetic catheter with multiple lumens for infusion of anesthetics and drainage of fluids within the surgical wound. It is manufactured from radiopaque materials, allowing for assessment of catheter placement after wound closure.

The device is supplied as a single-use or reusable product (not specified in the data) and is intended for use in general and plastic surgery. It received FDA 510(k) clearance with number K122661 on February 27, 2013, after being reviewed by the Anesthesiology advisory committee. The device is not specified as MRI safe, and no specific sizes or storage conditions are provided in the data.

Questions

AI-generated answers, 1 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 is the Vital 5 ReLeaf Catheter used for?

    The Vital 5 ReLeaf Catheter is designed as a conduction anesthetic catheter with multiple lumens for infusion of anesthetics and drainage of fluids within surgical wounds, intended for use in general and plastic surgery.

  • Is the Vital 5 ReLeaf Catheter single-use or reusable?

    The device is supplied as either a single-use or reusable product, though the specific usage type is not detailed in the available information.

  • What regulatory clearance has the Vital 5 ReLeaf Catheter received?

    The Vital 5 ReLeaf Catheter received FDA 510(k) clearance with number K122661 on February 27, 2013, after being reviewed by the Anesthesiology advisory committee.

  • What material is the Vital 5 ReLeaf Catheter made from?

    The catheter is manufactured from radiopaque materials, which allows for assessment of catheter placement after wound closure.