Strub Medical GmbH & Co. KG

FDA Device Registration & Listing · NEUHAUSEN Baden-Wurttemberg, DE · Registration 8010510

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
8010510
FEI Number
3000226659
Entity Name
Strub Medical GmbH & Co. KG
City/State/Country
NEUHAUSEN Baden-Wurttemberg, DE
Establishment Address
ROBERT-BOSCH-STR. 11, NEUHAUSEN Baden-Wurttemberg D78579, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Strub Medical GmbH & Co. KG (Owner Number: 8010510)
Owner / Operator Contact Address
ROBERT-BOSCH-STR. 11, --, NEUHAUSEN, DE-BW D78579, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JOS Electrode, Electrosurgical General, Plastic Surgery Class 2 878.4400 2023-02-04
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2023-02-04
GWG Endoscope, Neurological Neurology Class 2 882.1480 2023-02-04
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-02-04
HNF Scissors, Ophthalmic Ophthalmic Class 1 886.4350 2001-04-02
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-02-04
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2016-01-17
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2023-02-04
HQC Unit, Phacofragmentation Ophthalmic Class 2 886.4670 2022-09-01
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2025-05-04
FGC Urethroscope Gastroenterology, Urology Class 2 876.1500 2023-02-04
HOE Caliper, Ophthalmic Ophthalmic Class 1 886.4350 2019-07-29
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-02-04
HNM Needle, Ophthalmic Suturing Ophthalmic Class 1 886.4350 2011-12-13
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2023-02-04
NWW Hysteroscope Accessories Obstetrics/Gynecology Class 1 884.1690 2023-02-04
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-02-04

Official Correspondent

No official correspondent registered.

US Agent Details

Angelika Scherp Business: BUSINESS SUPPORT INTERNATIONAL Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

Strub Medical GmbH & 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
K936071 Smith & Nephew Dyonics, Inc. SMITH & NEPHEW DYONICS INC. ELECTRONIC ENDOSCOPE 1994-08-19
K953574 American Hydro-Surgical Instruments, Inc. NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER 1995-09-29
K914997 Conmedcorp ASP-IRRATOR 1992-01-07
K153773 Olympus Medical Systems Corp. Disposal Lens Cleaning Sheath 2016-11-22
K940141 Micro-Medical Devices, Inc. LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH 1994-05-19

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0037-05 N/A 2
NOVAPLUS Electrosurgical Grounding Pads, Split with Cord Catalog No. 7179V
Z-0023-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0025-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0026-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010510. Last updated year: 2026. Please use registration number 8010510 when referencing this establishment in official correspondence.
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