SUTURION AB

FDA Device Registration & Listing · LUND Skane, SE · Registration 3038138322

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3038138322
FEI Number
3038138322
Entity Name
SUTURION AB
City/State/Country
LUND Skane, SE
Establishment Address
Scheeleteorget 1, LUND Skane 22363, SE
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Suturion AB (Owner Number: 10093007)
Owner / Operator Contact Address
Scheeleteorget 1, LUND, SE-M 22363, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K242835
PMA Number
N/A

All Registered Proprietary Names

SutureTOOL system SutureTOOL

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2025-05-09
NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery Class 2 878.4840 2025-03-17

Official Correspondent

No official correspondent registered.

US Agent Details

Mittal Suthar Business: Target Health Email: msuthar@targethealth.com Phone: (857) 2336298

Related Public Records

Same Entity

Suturion AB
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3038138322. Last updated year: 2026. Please use registration number 3038138322 when referencing this establishment in official correspondence.
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