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MIDSLEEVE

by Medical Innovation Development

510(k) K142548Ref MID160

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K142548↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-FRMF000010145MID160AL Basic UDI-DI D-FRMF000010145MID160ALUDI-DIDate26 Sep 2025RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK142548 Date23 Jun 2015ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Model / Reference
MID160
Primary DI / UDI-DI
D-FRMF000010145MID160AL
Basic UDI-DI
B-FRMF000010145MID160AL
510(k) Number
FDA Product Code
KNT
EMDN Code
G020502 Gastric calibration tubes
Device Class
Class IIa EUDAMED
Class II 510(k)
Regulation
21 CFR Part 876.5980
EU market of registration
France
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class IIa
510(k)
Class II

Overview

AI-generated summary, 18 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 MIDSLEEVE is a calibration tube designed for use in sleeve gastrectomy procedures. It is intended to drain gastric fluid and provide calibration of the gastric pouch during Longitudinal Sleeve Gastrectomy (LSG), a bariatric surgery technique.

Supplied as a single-use device, the MIDSLEEVE is intended for sterile application in surgical settings. Authorized under FDA 510(k) clearance (K142548) and MDD compliance, it adheres to regulatory standards for medical devices in bariatric surgery. No MRI safety information or reusable specifications are provided in the data.

Questions

AI-generated answers, 18 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 purpose of the MIDSLEEVE during a sleeve gastrectomy procedure?

    The MIDSLEEVE is designed specifically for Longitudinal Sleeve Gastrectomy (LSG) procedures to drain gastric fluid and calibrate the gastric pouch during surgery. Its role ensures proper sizing and drainage, which are critical steps in creating the restricted stomach pouch for weight loss.

  • Is the MIDSLEEVE intended for reuse in multiple surgical procedures?

    No, the MIDSLEEVE is explicitly labeled as a single-use device. This classification aligns with sterile surgical requirements, ensuring patient safety and preventing cross-contamination between procedures.

  • How is the MIDSLEEVE authorized for use in the U.S. and Europe?

    In the U.S., the MIDSLEEVE holds FDA 510(k) clearance (K142548), confirming it is deemed substantially equivalent to a predicate device under the Traditional 510(k) review pathway. For Europe, it complies with MDD (Medical Device Directive) standards, meeting regulatory requirements for bariatric surgical tools.

  • Are there different sizes or models of the MIDSLEEVE available?

    The provided data does not specify variations in sizes or models for the MIDSLEEVE. However, since it is designed for calibration of the gastric pouch, it may be standardized to fit common pouch sizes used in LSG procedures. For exact sizing details, consulting the manufacturer’s technical documentation or contacting them directly would be advisable.

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No