Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010399422

FEI Number

3010399422

Entity Name

INVIDIA MEDICAL GMBH U CO KG

City/State/Country

Emmingen-Liptingen Baden-Wurttemberg, DE

Establishment Address

Carl-Benz-Str. 28, Emmingen-Liptingen Baden-Wurttemberg 78576, DE

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

INVIDIA Medical GmbH u CO KG (Owner Number: 10046503)

Owner / Operator Contact Address

Carl-Benz-Str. 28, Emmingen-Liptingen, DE-BW 78576, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PREMIUM UHD 4K ARTHRO/SINUSCOPE 175MM/70 /4MM Laparoscope, General and Plastic Surgery

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2016-11-29
HTX	Rongeur	Orthopedic	Class 1	888.4540	2016-11-29
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-11-29
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-11-29
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2014-11-03
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2016-03-10
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-11-29
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2018-08-30
KTG	Knife, Ent	Ear, Nose, Throat	Class 1	874.4420	2016-11-30
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2022-09-05
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2016-11-29
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2014-11-03
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2016-11-29
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	2016-11-29
EAY	Light, Fiber Optic, Dental	Dental	Class 1	872.4620	2018-08-30
GDR	Saw, Manual And Accessories	General, Plastic Surgery	Class 1	878.4800	2016-11-29
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2016-11-29
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2016-11-29
FFP	Dilator, Rectal	Gastroenterology, Urology	Class 1	876.5450	2016-11-29
NWW	Hysteroscope Accessories	Obstetrics/Gynecology	Class 1	884.1690	2019-12-03
GDN	Knife, Amputation	General, Plastic Surgery	Class 1	878.4800	2016-11-29
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)	Gastroenterology, Urology	Class 1	876.1500	2018-08-30
GCT	Light Source, Endoscope, Xenon Arc	Gastroenterology, Urology	Class 2	876.1500	2018-08-30
FHA	Clamp, Penile	Gastroenterology, Urology	Class 1	876.5160	2016-11-29
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-11-29
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-03-08
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-11-29
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2016-11-29
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-11-29
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2016-11-29
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2016-11-29
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-03-10
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-11-29
KBJ	Curette, Adenoid	Ear, Nose, Throat	Class 1	874.4420	2016-11-29
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	Class 1	874.4420	2016-11-29
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2022-09-05
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-09-05
KBA	Rasp, Nasal	Ear, Nose, Throat	Class 1	874.4420	2014-11-03
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-11-29
KAD	Elevator, Ent	Ear, Nose, Throat	Class 1	874.4420	2016-11-29
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-03-08
OFO	Airway Suction Kit	Anesthesiology	Class 1	868.6810	2024-05-08
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2016-11-29
FWB	Camera, Television, Surgical, Without Audio	General, Plastic Surgery	Class 1	878.4160	2018-08-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-03-31
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2016-11-30
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-11-29
FFL	Dislodger, Stone, Basket, Ureteral, Metal	Gastroenterology, Urology	Class 2	876.4680	2020-01-22
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2018-08-30
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-11-29
HNZ	Curette, Ophthalmic	Ophthalmic	Class 1	886.4350	2016-11-29
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2022-07-11
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-07-11
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2022-07-11
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2016-11-29
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-09-19
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2020-01-22
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2016-03-08

Official Correspondent

Michael Hainke

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

INVIDIA Medical GmbH u CO KG

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
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K953012	Boston Surgical Products, Inc.	DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS	1995-07-12
K831824	Silverman'S	DENTAL ELECTRONIC/S.B.R TRADING BU HAND	1983-08-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
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.
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010399422. Last updated year: 2026. Please use registration number 3010399422 when referencing this establishment in official correspondence.