Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1225492

FEI Number

3001237338

Entity Name

NextPhase Medical Devices LLC

City/State/Country

ROCHESTER, NH, US

Establishment Address

88 Airport Dr, ROCHESTER, NH 03867, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

NextPhase Medical Devices LLC (Owner Number: 9026654)

Owner / Operator Contact Address

88 AIRPORT DR., Rochester, NH 03867, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K181170

PMA Number

N/A

All Registered Proprietary Names

23-314-1 BIPOLAR SEALER AQM MINI EVS3.4 23-121-1 BIPOLAR SEALER AQM EVS 23-113-1 BIPOLAR SEALER AQM 2.3 23-312-1 BIPOLAR SEALER AQM SBS 5 BITE BLOK AEVUMED PHANTOM-LP SUTURE ANCHORS BIT 9733518 3.5MM Drill Sterile Patient Tracker 9734887 Non-Invasive Patient Tracker 9735300 Skull Mount PKGD Shunt Kit 9733605 Non-Invasive Shunt Kit 9733606 Skull Mounted 9733606-G02 Patient Tracker 9734887XOM Non-Invasive BIT 9733517 3MM Drill Sterile Stylet 9735428 2 Coil Single Package BIT 9733519 3MM Cannulated Sterile Shunt Kit 9733606 Skull Mounted Philips Fisher & Paykel RT265 Circuit (1141548) Philips Fisher & Paykel 900MR810 Circuit (1141549) Aquamantys 6 Bipolar Sealer AEVUMED RAPID SUTURE ANCHORS ART CARTRIDGE KIT 23-321-1 AQM MIS FLEX 23-322-1 AQM MIS FLEX MINI AxiEM Philips Fisher & Paykel RT211 Circuit (1141427) AEVUMED PHANTOM SUTURE ANCHORS INVOcell STALIF C STALIF C-Ti MIDLINE II MIDLINE II-Ti STALIF MIDLINE PAK 9733498NAV NAVIGATED PEDICLE ACCESS Kit PAK 9733497NAV NAV NIM-SPINE PEDICLE ACCESS KIT Pak 9733497 NAV NIM-SPINE PEDICLE ACC KIT PAK 9733498 NAVIGATED PEDICLE ACCESS KIT SMARTPICC ACCESSORY PACK Suction 9735019 Malleable STD TIP 12-FR Suction 9735015 Malleable STD Tip 7-FR Suction 9735018 Malleable Ball Tip 9-FR Suction 9735017 Malleable Angle Tip 9-FR Suction 9735016 Malleable STDTIP 9-FR Malleable Bipolar Sealer with Light Philips Disp External Flow Sensor, Pediatric/Infant, 10/PK (1146558) Philips Disp External Flow Sensor, Adult/Pediatric, 10/PK (1147497) Philips Dual LimAEV Single PK (1132110) Philips Dual LimAEV10/PK (1139436) Philips External Flow Sensor Cable (1134592) Philips Trilogy EV300, External Flow Sensor Assembly with Cable, Adult/Pediatric (1132106)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-04-17
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2014-05-19
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-11-25
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2016-03-14
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2020-07-09
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2020-07-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-10-23
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-11-25
QYK	Semi-Automated Autologous Skin Graft Harvesting And Application Device	General, Plastic Surgery	Class 2	878.4795	2024-11-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-04-17
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2012-11-19
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2020-07-09
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-11-25
OYO	Culture, Intravaginal, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6165	2022-03-08
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2024-04-17
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2024-04-17
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2016-02-15
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2016-02-15
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2026-02-24
PGW	Ear, Nose, And Throat Stereotaxic Instrument	Neurology	Class 2	882.4560	2016-02-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-11-09
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2020-07-09

Official Correspondent

James Bennett

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NextPhase Medical Devices LLC

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
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
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

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-0001-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.

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3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1225492. Last updated year: 2026. Please use registration number 1225492 when referencing this establishment in official correspondence.