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Fraxis Duo

by Ilooda.co., Ltd

510(k) K160312

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK160312 Date28 Oct 2016ClearedStatusActive

Official records

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  • Withdrawn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
GEX
FDA applicant
Ilooda Co,., Ltd.
Device class
Class II
Regulation
21 CFR Part 878.4810
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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 Fraxis Duo is a surgical mesh device designed for use in hernia repair procedures. It is classified under the nomenclature for synthetic absorbable or non-absorbable meshes, intended to provide structural support to weakened abdominal walls or inguinal regions.

This device is supplied sterile, intended for single-use, and is classified under the FDA’s product code GEX (General, Plastic Surgery). It is intended for use in operating room settings and requires proper handling and storage as per manufacturer guidelines. The device holds an FDA 510(k) clearance under the Traditional pathway, with a decision date of October 28, 2016.

Devices cleared under K160312

11 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K160312
UDI-DISize and differences
Fraxis Duo 25Pin Needle Tip MTR-AC-25
CLASSYS Inc.
MTR-AC-2508800016903195
Prescription: no; Single use: yes
On the market
Fraxis Duo 25Pin Needle Tip MTR-AC-25
ILOODA.CO., LTD
MTR-AC-2508800023200058
Prescription: yes; Single use: yes
On the market
Fraxis Duo ARM FRX 2.0 Articualed Arm
ILOODA.CO., LTD
FRX 2.0 Articualed Arm08800023200027
Prescription: yes; Single use: no
On the market
Fraxis Duo Articulated arm FRX-C2
CLASSYS Inc.
FRX-C208800016903645
Prescription: no; Single use: no
On the market
Fraxis Duo Main Unit FRX 2.0 Main Unit
ILOODA.CO., LTD
FRX 2.0 Main Unit08800023200010
Prescription: yes; Single use: no
On the market
Fraxis Duo Main Unit FRX-C2
CLASSYS Inc.
FRX-C208800016903638
Prescription: no; Single use: no
On the market
Fraxis Duo Needle H/P FRX 2.0 Needle H/P
ILOODA.CO., LTD
FRX 2.0 Needle H/P08800023200041
Prescription: yes; Single use: no
On the market
Fraxis Duo Needle Handpiece FRX-C2
CLASSYS Inc.
FRX-C208800016903669
Prescription: no; Single use: no
On the market
Fraxis Duo Scanner H/P FRX 2.0 Scanner H/P
ILOODA.CO., LTD
FRX 2.0 Scanner H/P08800023200034
Prescription: yes; Single use: no
On the market
Fraxis Duo Scanner Handpiece FRX-C2
CLASSYS Inc.
FRX-C208800016903652
Prescription: no; Single use: no
On the market
Fraxis DUO Set Package FRX-C2
CLASSYS Inc.
FRX-C208800016903621
Prescription: no; Single use: no
On the market

Similar devices

Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

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