Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012445569

FEI Number

3012445569

Entity Name

ACCURATUS AG

City/State/Country

Bern, CH

Establishment Address

Holligenstrasse 94, Bern 3008, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Accuratus AG (Owner Number: 10050192)

Owner / Operator Contact Address

Holligenstrasse 94, Bern, CH-BE 3008, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RASP CHISEL, SURGICAL, MANUAL Punch, Surgical RETRACTOR HANDLE, SCALPEL HAMMER, SURGICAL ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY HOOK, SURGICAL, GENERAL & PLASTIC SURGERY

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2015-10-20
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2015-10-20
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2021-04-14
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2015-10-20
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2015-10-20
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-10-20
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-10-20
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2015-10-20

Official Correspondent

Patrick Kueffer

US Agent Details

Ron Dyches Business: OrthoMed Inc. Email: ron@orthomedinc.com Phone: (800) 5475571

Related Public Records

Same Entity

Accuratus AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

Similar Registrations

Registration Number	Establishment Name	Location
3004176895	BK MEDITECH CO., LTD.	Hwaseong-si Gyeonggi, KR
3014334038	Integra LifeSciences Production Corporation	Mansfield, MA, US
3033509898	STRAITS ORTHOPAEDICS (MFG) SDN BHD	Bandar Cassia Pulau Pinang, MY
2431166	Sklar Corporation	West Chester, PA, US
3000931034	Tornier S.A.S.	Montbonnot Saint-Martin Isere, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012445569. Last updated year: 2026. Please use registration number 3012445569 when referencing this establishment in official correspondence.