GYRUS MEDICAL LTD.

FDA Device Registration & Listing · CARDIFF Wales, GB · Registration 9617070

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
9617070
FEI Number
3002807134
Entity Name
GYRUS MEDICAL LTD.
City/State/Country
CARDIFF Wales, GB
Establishment Address
FORTRAN RD., ST. MELLONS, CARDIFF Wales CF3 0LT, GB
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
ATL Technology LLC (Owner Number: 10045899)
Owner / Operator Contact Address
1335 West 1650 North, Springville, UT 84663, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Versapoint Bipolar Electrode Resectoscopic Vaporizing Tip (0°) PLASMAKINETIC SUPERPULSE SYSTEM PK SuperLoop Instrument PLASMAKINETIC SUPERPULSE SYSTEM PK SuperSect Instrument PLASMAKINETIC SUPERPULSE SYSTEM Footswitch PLASMAKINETIC SUPERPULSE SYSTEM PK SuperSect Instrument PLASMAKINETIC SUPERPULSE SYSTEM PK SuperLoop Instrument PLASMAKINETIC SUPERPULSE SYSTEM Footswitch PLASMAKINETIC SUPERPULSE SYSTEM SuperLoop PK Front Loading Electrode PLASMAKINETIC SUPERPULSE SYSTEM SuperSect PK Front Loading Electrode VAPR CoolPulse 90 Electrode with Hand Controls VAPR Premiere90 with Integrated Handpiece VAPR S50 Electrode with Integrated Handpiece VAPR CoolPulse 90 Electrode without Hand Controls VAPR Premiere50 Electrode with Integrated Handpiece Single Use Plasma Coagulation Probe Axial Argon PA-211U, 2.3 x 2200 mm Single Use Plasma Coagulation Probe Lateral Argon PA-221U, 2.3 x 2200 mm Pressure reducer, with connector acc. to CGA No. 580, for Argon Plasma Coagulation Single Use Plasma Coagulation Probe Axial Argon PA-211Z, 2.3 x 3000 mm Single Use Plasma Coagulation Probe Axial Argon PA-212U, 3.2 x 2200 mm Single Use Plasma Coagulation Probe Axial Argon PA-210K, 1.5 x 1500 mm Single Use Plasma Coagulation Probe Radial Argon PA-231U, 2.3 x 2200 mm Single Use Plasma Coagulation Probe Axial Argon PA-210Z, 1.5 x 3000 mm VAPR 2.3 Wedge Electrode VAPR® 2.3 Wedge Electrode (Short) PK Plasma-V Instrument Versapoint II Connector Cable Versapoint II Bipolar Electrode Resectoscopic 4 mm Angled Loop, Resecting Versapoint II Electrosurgical Generator Versapoint II Footswitch VAPR Flexible Side Effect Electrode VAPR End Effect Electrode VAPR Side Effect Electrode VAPR 90 Degree Hook Electrode VAPR Flexible End Effect Electrode VAPR Angled Side Effect Electrode VAPR Angled End Effect Electrode VAPR Handpiece VAPR S90 Electrode VAPR 3 Footswitch Monopolar Single-Use HF Cable VAPR Flexible Side Effect Electrode VAPR Flexible End Effect Electrode PK Lap Loop VAPR 2.3 Side Effect Electrode VAPR 2.3 Side Effect Electrode (Short) VAPR Premiere50 VAPR S50 Electrode VAPR® Premiere90 VAPR S90 Electrode VAPR P50 Hand Switching VAPR Hook Hand Switching VAPR 2.3 Wedge Hand Switching VAPR CoolPulse 90 Electrode with Hand Controls VAPR Side Effect Hand Switching VAPR VUE Wireless Footswitch VAPR CoolPulse 90 Electrode without Hand Controls VAPR VUE Generator VAPR S90 Hand Switching PLASMAKINETIC SYSTEM PK Plasma-Sect Instrument - Angled Loop Resecting PLASMAKINETIC SYSTEM PK Plasma-Sect Instrument - Angled Loop Resecting 4mm VAPR Hook Electrode with Integrated Handpiece VAPR Premiere50 Electrode Integrated Handpiece VAPR S90 Electrode with Integrated Handpiece VAPR Side Effect Electrode with Integrated Handpiece VAPR 2.3 Wedge Electrode with Integrated Handpiece VAPR® 2.3 End Effect Electrode Versapoint Bipolar Electrode Resectoscopic 2.5 mm Angled Loop, Resecting PK Button Versapoint Bipolar Electrode Resectoscopic Vaporizing Tip (0°) VAPR Tripolar 90 Suction Electrode VAPR CoolPulse Curve Suction Electrode XL VAPR CoolPulse Curve Suction Electrode VAPR Hook Electrode VAPR 2.3 Wedge Electrode VAPR S90 Electrode VAPR Side Effect Electrode VAPR Premiere50 Electrode PLASMAKINETIC SYSTEM PK Plasma-V Instrument VAPR ARCTIC Suction Electrode Chisel Tip VAPR ARCTIC Suction Electrode Dome Tip

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2023-05-05
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2023-05-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-05
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2023-05-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-05
HRX Arthroscope Orthopedic Class 2 888.1100 2023-05-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-05
FDC Resectoscope, Working Element Gastroenterology, Urology Class 2 876.1500 2023-05-05
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2023-05-05
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2023-05-05
HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4150 2023-05-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-05
HRX Arthroscope Orthopedic Class 2 888.1100 2023-05-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-05
HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4150 2023-05-05
HRX Arthroscope Orthopedic Class 2 888.1100 2023-05-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-05
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2023-05-05
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2023-05-05
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2023-05-05
FDC Resectoscope, Working Element Gastroenterology, Urology Class 2 876.1500 2023-05-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-05
HRX Arthroscope Orthopedic Class 2 888.1100 2023-05-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-05
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2023-05-05
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2023-05-05
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2023-05-05
HFG Coagulator, Laparoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2023-05-05
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2023-05-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-05
FDS Gastroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2023-05-05
KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories) Gastroenterology, Urology Class 2 876.4300 2023-05-05
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-05-05

Official Correspondent

No official correspondent registered.

US Agent Details

Lauren Cordova Business: ATL Technology Email: lauren.cordova@atlmedical.com Phone: (801) 8534035

Related Public Records

Same Entity

ATL Technology LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007015148 ATL TECHNOLOGY LLC Springville, UT, US
3010280625 ATL Technology DG,Ltd. Dongguan Guangdong, CN
3012263546 ATL Technology CR Limitada Alajuela, CR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K935716 KARL STORZ Endoscopy-America, Inc. KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE 1995-11-16
K950499 American Hydro-Surgical Instruments, Inc. NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS 1995-06-16
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0041-05 Linvatec Corp. 2
Ultra Power Burs, Sterile, Single-Use.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617070. Last updated year: 2026. Please use registration number 9617070 when referencing this establishment in official correspondence.
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