Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015972753

FEI Number

3015972753

Entity Name

STERISERVICE SP. Z O.O.

City/State/Country

Czestochowa Slaskie, PL

Establishment Address

ul. Ekonomiczna 5, Czestochowa Slaskie 42-200, PL

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

Steriservice Sp. z o.o. (Owner Number: 10061367)

Owner / Operator Contact Address

Fabryczna 13/1, Zielona Góra, PL-08 65-410, PL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LiNA SkinHook, small blunt, dual pack LiNA SkinHook, smal, angled, extra sharp, dual pack LiNA SkinHook, large blunt, dual pack LiNA SeaStar, SS model LiNA SeaStar, VS model LiNA SeaStar, SL model LiNA SeaStar, squared model LiNA SkinHook, small sharp, dual pack LiNA SeaStar, VV model LiNA SeaStar, VL model C-CAT Anesthesia Catheter LiNA OperaScope with HDMI cable LiNA OperaScope Needle (OP-NEE4-6) LiNA OperaScope Needle (OP-NEE8-6) LiNA PowerBlade Plus LiNA PowerBlade Plus HC LiNA CystoVu HD Grasper LiNA CystoVu HD Disposable needle guide for 9029 Biopsy guide for 8818 Endfire biopsy guide for 8818 Biplane biopsy guide for 8818 Dual biopsy guide for 8818 LiNA OperaScope for hysteroscopy and cystocopy with HDMI cable & LCD 956-624 SafePICO70 23Gx25 mm 956-616 SafePICO Self-fill 23Gx25 mm 956-612 SafePICO Self-fill 23Gx16 mm 956-610 SafePICO Self-fill 956-609 SafePICO70 23Gx16 mm 956-608 SafePICO70 22Gx32 mm 956-613 SafePICO Self-fill 22Gx25 mm 956-615 SafePICO Self-fill 23Gx16 mm 956-623 SafePICO Self-fill 25Gx16 mm 956-614 SafePICO Self-fill 22Gx32 mm LiNA OperaScope Scissors LiNA OperaScope Angled Lasso LiNA OperaScope Lasso LiNA OperaScope Rat Tooth Alligator Grasper for hysteroscopy and cystoscopy LiNA OperaScope Biopsy Forceps for hysteroscopy and cystoscopy ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES LiNA Bipolar Loop (BL-160) LiNA Bipolar Loop (BL-200) LiNA Bipolar Loop (BL-240) LiNA OperaScope Angled Lasso (OP-LAS10A-3) LiNA OperaScope Lasso (OP-LAS16-3) LiNA OperaScope Angled Lasso (OP-LAS16A-3) LiNA OperaScope Lasso (OP-LAS10-3)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2019-10-11
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2026-04-20
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2019-10-14
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2026-01-30
FBK	Endoscopic Injection Needle, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2026-01-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-01-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-01-30
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2026-01-30
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-11-12
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-09-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-10-14
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2026-01-29
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-01-05
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2022-01-05
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-07-24
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2025-07-24
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2019-10-14
NVT	Tubing And Tubing/Filter Fits	Obstetrics/Gynecology	Class 1	884.1700	2019-10-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-11-12
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-11-12
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2022-01-05
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2023-09-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-04-20
HIN	Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4150	2019-10-14
GAE	Snare, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-10-14

Official Correspondent

Bartosz Rogacki

US Agent Details

Robert Packard Business: Medical Device Academy Incorporated Email: rob@fdaestar.com Phone: (802) 2581881

Related Public Records

Same Entity

Steriservice Sp. z o.o.

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
K072702	Stryker Instruments, Instruments Div.	STRYKER ANTIMIC CATHETER	2008-03-19
K935716	KARL STORZ Endoscopy-America, Inc.	KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE	1995-11-16

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-0020-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4702
Z-0021-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4704
Z-0022-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4712
Z-0023-2023	Hobbs Medical, Inc.	2	Hobbs Posi-Stop Injection Needle Catalog Number: 4718

Similar Registrations

Registration Number	Establishment Name	Location
3011050528	FREEHOLD SURGICAL, INC.	New Hope, PA, US
3021006167	KIMS MED CO., LTD.	Gwangju, KR
3045009502	WISDOM MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD	Shanghai, CN
3032847175	BIOPHYX SURGICAL, INC.	Edgewater, MD, US
9681129	BEMA-GMBH & CO. KG	EMMINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015972753. Last updated year: 2026. Please use registration number 3015972753 when referencing this establishment in official correspondence.