HENKE-SASS WOLF, GMBH.

FDA Device Registration & Listing · TUTTLINGEN Baden-Wurttemberg, DE · Registration 8010418

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
8010418
FEI Number
3007130719
Entity Name
HENKE-SASS WOLF, GMBH.
City/State/Country
TUTTLINGEN Baden-Wurttemberg, DE
Establishment Address
KELTENSTRASSE 1, TUTTLINGEN Baden-Wurttemberg 78532, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
HENKE-SASS WOLF, GMBH. (Owner Number: 8010418)
Owner / Operator Contact Address
Keltenstrasse 1, --, TUTTLINGEN, DE-BW D-78532, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

FSM Bariatric Laparoscope Inflow Cannula Adapter Resection Instruments Laparoscope FAJ XION Laparoscopes HSW Laparosopes & Accessories Endoscope med reusable Fine-Ject Video Ureteroscope Soft-Ject Norm-Ject HSW Arthroscope 5MM 30° BARIATRIC LAPAROSCOPE, AC HD 10MM 0 DEGREES BARIATRIC IR LAPARSCOPE, AC 10MM 45° BARIATRIC LAPAROSCOPE, AC HD 5MM 30 DEGREES BARIATRIC IR LAPARSCOPE, AC 10MM 45° AUTOCLAVABLE BARIATRIC LAPAROSCOPE, 45CM 10MM 0° AUTOCLAVABLE BARIATRIC LAPAROSCOPE, 45CM 10MM 30° AUTOCLAVABLE BARIATRIC LAPAROSCOPE, 45CM HD 5MM 0 DEGREE BARIATRIC IR LAPARASCOPE, AC 10MM 0° BARIATRIC LAPAROSCOPE, AC HD 5MM 45° BARIATRIC LAPAROSCOPE, AC HD 10MM 30 DEGREES BARIATRIC IR LAPARSCOPE, AC HD 5MM 45 DEGREES BARIATRIC IR LAPARSCOPE, AC HD 10MM 45 DEGREES BARIATRIC IR LAPARSCOPE, AC 10MM 30° BARIATRIC LAPAROSCOPE, AC HD 5MM 0° BARIATRIC LAPAROSCOPE, AC Nasopharyngoscope (flexible / rigid) Laparoscope, general and plastic surgery EOB XION Sinuscppes HSW Nasopharyngoscope & Accessories HSW Hysteroscope & Accessories Sheat HD 2.7MM X 70° ARTHROSCOPE SPEEDLOCK A/C HD 4MM X 70° ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C 2.3MM X 30 DEG, C-,MOUNT, REVERSE CANT, A/C IDEAL EYES PRECISION HD, 4MM, 30 DEG., AUTOCLAVABLE ARTHROSCOPE, C-MOUNT, 140MM, SPEEDLOCK 2.7MM 70 DEG AUTOCLAVABLE ARTHROSCOPE HD 2.3MM X 0° ARTHROSCOPE J-LOCK A/C 4MM 70° AUTOCLAVABLE HIP ARTHROSCOPE 4MM X 70° LONG ARTHROSCOPE SPEEDLOCK A/C HD 2.3MM X 30 DEGREE REVERSE CANT ARTHROSCOPE, J-LOCK, C-MOUNT, A/C 2.3MM X 70 DEG, C-,MOUNT, A/C HD 2.7MM X 30° STUBBY ARTHROSCOPE J-LOCK A/C 2.7MM 0° C-MOUNT, ARTHROSCOPE HD 70 DEG., ARTHROSCOPE, 4MM X 165MM, C-MOUNT, SPEEDLOCK, A/C HD 2.7MM X 70° STUBBY ARTHROSCOPE J-LOCK A/C 4MM 30° AUTOCLAVABLE ARTHROSCOPE, C-MOUNT 1.9MM X 30º C-MOUNT, A/C 4MM 0DEG C-MOUNT 2.7MM X 30° STUBBY AUTOCLAVABLE STUBBY SCOPE REVERSE CANT HD 1.9MM X 30 DEGREE ARTHROSCOPE, J-LOCK, C-MOUNT, A/C 2.7MM 0° NON-A/C STUBBY ARTHROSCOPE W/SPEEDLOCK, C-MOUNT HD 2.3MM X 30° REVERSE CANT ARTHROSCOPE J-LOCK A/C HD 4MM X 0° ARTHROSCOPE SPEEDLOCK A/C IDEAL EYES 30° ARTHROSCOPE, 2.9 X 200 MM, EYEPIECE, SPEED-LOCK, AUTOCLAVABLE (SPA EYEPIECE SCOPE) HD 2.3MM X 70 DEGREE ARTHROSCOPE, J-LOCK, C-MOUNT, A/C HD 4MM X 70 DEG LONG ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C HD 2.3MM X 30° ARTHROSCOPE J-LOCK A/C 2.9MM IDEAL EYES PRECISION HD AUTOCLAVABLE 200MM C-MOUNT ARTHROSCOPE - 30 DEG. WITH MODIFIED SPEEDLOCK HD 2.7MM X 0 DEGREE ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C 2.3MM X 0 DEG, C-,MOUNT, A/C HD 30 DEG., 4MM X 165MM, C-MOUNT, SPEEDLOCK, A/C 4MM X 30° LONG ARTHROSCOPE SPEEDLOCK A/C 2.3MM X 30 DEG, A/C 2.7MM 30° AUTOCLAVABLE ARTHROSCOPE WITH SPEED-LOCK, C-MOUNT HD 4MM X 0° ARTHROSCOPE, SPEEDLOCK, C-MOUNT HD 2.7MM X 30 DEGREE REVERSE CANT STUBBY ARTHROSCOPE, J-LOCK, C-MOUNT, A/C HD 2.3MM X 70° ARTHROSCOPE J-LOCK A/C HD 2.3MM X 30 DEGREE ARTHROSCOPE, J-LOCK, C-MOUNT, A/C 4MM 0° C-MOUNT STYLE A ARTHROSCOPE 4MM 70° LONG AUTOCLAVABLE ARTHROSCOPE, 16.5 CM 4MM 70° AUTOCLAVABLE ARTHROSCOPE, C-MOUNT HD 2.7MM X 0° STUBBY ARTHROSCOPE J-LOCK A/C 4MM A/C ARTHROSCOPE 4MM 0° LONG AUTOCLAVABLE ARTHROSCOPE, 16.5CM HD 2.7MM X 70 DEGREE STUBBY ARTHROSCOPE, J-LOCK, C-MOUNT, A/C IDEAL EYES PRECISION HD, 4MM, 70 DEG., AUTOCLAVABLE ARTHROSCOPE, C-MOUNT, 140MM, SPEEDLOCK 4MM X 0° LONG ARTHROSCOPE SPEEDLOCK A/C 4MM 30° LONG AUTOCLAVABLE ARTHROSCOPE, 16.5CM PKG, 1.9MM TMJ, AUTOCLAVABLE 2.7MM 30°C-MOUNT, ARTHROSCOPE HD 4MM X 30° ARTHROSCOPE SPEEDLOCK A/C 4MM 30° AUTOCLAVABLE HIP ARTHROSCOPE HD 4MM X 30° REVERSE CANT LONG ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C HD 4MM X 30° LONG ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C 2.7MM 70° A/C STUBBY ARTHROSCOPE WITH SPEED-LOCK, C-MOUNT HD 30 DEG, ARTHROSCOPE, 4MM X 165MM, C-MOUNT, SPEEDLOCK, A/C, REVERSE CANT 2.7MM STUBBY SCOPE AUTOCLAVABLE HD 4MM X 30° REVERSE CANT ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C HD 1.9MM X 30° ARTHROSCOPE J-LOCK A/C HD 1.9MM X 0° ARTHROSCOPE J-LOCK A/C 2.7MM 30 DEG AUTOCLAVABLE ARTHROSCOPE HD 2.7MM X 30° ARTHROSCOPE SPEEDLOCK A/C 2.7MM 30° NON-A/C STUBBY ARTHROSCOPE W/SPEEDLOCK, C-MOUNT IDEAL EYES PRECISION HD, 4MM, 30 DEG., AUTOCLAVABLE ARTHROSCOPE, C-MOUNT, 140MM, REVERSE CANT, SPEEDLOCK 4MM 70° C-MOUNT STYLE A ARTHROSCOPE HD 4MM X 30° ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C 4MM AUTOCLAVABLE ARTHROSCOPE 2.3MM 30° NON-AUTOCLAVABLE ARTHROSCOPE W/SPEEDLOCK,C-MOUNT 2.7MM X 0 DEG, C-MOUNT, A/C 2.7MM X 70DEG STUBBY, A/C 2.7MM 0 DEG AUTOCLAVABLE ARTHROSCOPE HD 2.3MM X 0 DEGREE ARTHROSCOPE, J-LOCK, C-MOUNT, A/C IDEAL EYES PRECISION HD, 4MM, 0 DEG., AUTOCLAVABLE ARTHROSCOPE, C-MOUNT, 140MM, SPEEDLOCK HD 4MM X 45° ARTHROSCOPE, SPEEDLOCK, A/C 2.7MM 0° C-MOUNT, STUBBY 2.7MM 30° C-MOUNT, STUBBY 1.9MM 30° NON-AUTOCLAVABLE ARTHROSCOPE W/SPEEDLOCK, C-MOUNT HD 2.7MM X 0° ARTHROSCOPE SPEEDLOCK A/C 4MM 30° C-MOUNT STYLE A ARTHROSCOPE HD 2.7MM X 30 DEGREE ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C 2.3MM X 0 DEG, A/C HD 2.7MM X 70 DEGREE ARTHROSCOPE, SPEEDLOCK, C-MOUNT, A/C 4MM 0° AUTOCLAVABLE ARTHROSCOPE, C-MOUNT HD 1.9 X 0 DEGREE ARTHROSCOPE, J-LOCK, C-MOUNT, A/C 4MM 30° AUTOCLAVABLE REVERSE CANT ARTHROSCOPE, C-MOUNT HD 4MM X 70° ARTHROSCOPES, SPEEDLOCK, A/C 2.7MM X 30 DEG, C-MOUNT, A/C 2.3MM X 30 DEG, C-,MOUNT, A/C HD 4MM X 30° REVERSE CANT ARTHROSCOPE SPEEDLOCK A/C HD 2.7MM X 0 DEGREE STUBBY ARTHROSCOPE, J-LOCK, C-MOUNT, A/C HD 2.7MM X 30 DEGREE STUBBY ARTHROSCOPE, J-LOCK, C-MOUNT, A/C XION Hysteroscopes 4.4MM HIP OBTURATOR CANNULATED BLUNT TIP OBTURATOR FOR 2.9MM CANNULA 1.9MM SPEEDLOCK PENCIL TIP OBTURATOR CANNULA, 2.8MM ONE FIXED STOPCOCK 2.3MM AUTOCLAVABLE PENCIL TIP OBTURATOR WITH SPEED-LOCK 3.2MM CANNULA WITH 2 FIXED STOPCOCKS TROCAR FOR 2.9MM CANNULA TROCAR FOR 2.8MM CANNULA CANNULA, 3.2MM ONE FIXED STOPCOCK BLUNT TIP OBTURATOR FOR 3.2 CANNULA CANNULA, 3.2MM TWO ROTATING STOPCOCKS PENCIL TIP OBTURATOR FOR 2.8MM J-LOCK CANNULA 3.2MM CANNULA WITH 1 ROTATING STOPCOCK 2.8MM CANNULA WITH 1 ROTATING STOPCOCK 1.9MM OBTURATOR 5.8MM HIPSCOPE CANNULA, 2 ROTATING STOPCOCKS 2.7MM OBTURATOR TROCAR FOR 3.2 CANNULA CANNULA, 2.8MM TWO FIXED STOPCOCKS 2.7MM SPEEDLOCK PENCIL TIP OBTURATOR 2.7MM TROCAR CANNULA, 3.2MM ONE ROTATING STOPCOCK 3.2MM SPEEDLOCK PENCIL TIP OBTURATOR BLUNT TIP OBTURATOR FOR 2.8MM CANNULA PENCIL TIP OBTURATOR FOR 3.2MM CANNULA 4MM, 30 HIP ARTHOSCOPE (HIPSCOPE) 2.8MM TWO ROTATING STOPCOCKS CANNULA, 4MM ONE FIXED STOPCOCK PENCIL TIP OBTURATOR FOR 2.8MM CANNULA 2.9MM AUTOCLAVABLE CANNULA, 1 ROTATING STOPCOCK W/SPEEDLOCK PENCIL TIP OBTURATOR FOR 4MM CANNULA 1.9MM TROCAR TROCAR FOR 4MM CANNULA 2.9MM CANNULA WITH 1 ROTATING STOPCOCK CANNULA, 3.2MM TWO FIXED STOPCOCKS 2.3MM AUTOCLAVABLE TROCAR FOR 2.9MM CANNULA WITH SPEED-LOCK TROCAR FOR 2.8MM J-LOCK CANNULA 3.2MM CANNULA WITH 2 ROTATING STOPCOCKS CANNULA, 2.8MM ONE ROTATING STOPCOCK 2.3MM OBTURATOR 4.4MM HIP TROCAR CANNULATED 4MM CANNULA WITH 2 FIXED STOPCOCKS 3.2MM CANNULA WITH 1 FIXED STOPCOCK PENCIL TIP OBTURATOR FOR 2.9MM CANNULA 2.3MM TROCAR 2.8MM CANNULA WITH 2 ROTATING STOPCOCKS 4MM CANNULA WITH 1 ROTATING STOPCOCK BLUNT TIP OBTURATOR FOR 4MM CANNULA 2.3MM AUTOCLAVABLE BLUNT TIP OBTURATOR WITH SPEED-LOCK 2.8MM CANNULA WITH 1 FIXED STOPCOCK 4MM CANNULA WITH 2 ROTATING STOPCOCKS WORKING ELEMENT, 22/24FR RESECTOSCOPE SHEATH, 2.9MM DIAGNOSTIC INNER SIDE FIRE LASER OUTER SHTH SHEATH, 2.9MM OPERATIVE INNER ELLIK EVACUATOR 27/28FR RESECTOSCOPE STANDARD OBTURATOR HYSTEROSCOPE, 2.9MM 0DEG 25FR VISUAL URETHROTOME OUTER SHEATH COLD KNIFE, STRAIGHT SHEATH, 22/24FR RESECTOSCOPE INNER 23FR CYSTO VISUAL OBTURATOR 21FR VISUAL URETHROTOME OPTICAL BRIDGE ELLIK ADAPTER CYSTO SHEATH HTA ADAPTER, 2.9MM HYSTEROSCOPE 21FR URETHROTOME STANDARD OBTURATOR 25FR CYSTO STANDARD OBTURATOR 19FR CYSTO VISUAL OBTURATOR HYSTEROSCOPE, 2.9MM 30DEG 17FR CYSTO STANDARD OBTURATOR HTA SCOPE BRIDGE HYSTEROSCOPE, 4MM 30DEG AUTOCLAVABLE SHEATH, 22/24FR RESECTOSCOPE OUTER OBTURATOR, 4MM OPERATIVE 4MM CYSTOSCOPE, KS SERIES 0DEG SHEATH, 2.9MM DIAGNOSTIC OUTER 24/26FR RESECTOSCOPE VISUAL OBTURATOR PORT SEAL 21FR CYSTOSCOPE SHEATH 27FR STANDARD FLOW RESECTOSCOPE SHEATH SHEATH, 4MM DIAGNOSTIC INNER 27FR STANDARD FLOW RESECTOSCOPE SHEATH ADAPTER CYSTOSCOPE, 4MM 70 DEG AUTOCLAVABLE SHEATH, 4MM OPERATIVE INNER COLD KNIFE, HOOK COLD KNIFE, LOOP RIGID OPTICAL STONE CRUSHING FORCEP 30° CYSTOSCOPE, 4MM 30 DEG WITH GREEN LIGHT FILTER AUTOCLAVABLE 23FR CYSTO STANDARD OBTURATOR 4MM HYSTERSCOPE OPERATIVE SHEATH (7MM DIAMETER) 25FR CYSTO VISUAL OBTURATOR WORKING ELEMENT- ACTIVE (BAUMRUCKER) HYSTEROSCOPE, 4MM 0DEG AUTOCLAVABLE BLADDER SYRINGE ADAPTER, OUTER SHEATH CYSTOSCOPE, 4MM 30 DEG AUTOCLAVABLE 19FR CYSTOSCOPE SHEATH OBTURATOR, 2.9MM OPERATIVE 21FR CYSTO STANDARD OBTURATOR 4MM CYSTOSCOPE, KS SERIES 30DEG RIGID OPTICAL BIOPSY FORCEP 0°, 12° SINGLE HORN BRIDGE BLADDER SYRINGE ADAPTER CYSTO SHEATH RIGID OPTICAL STENT REMOVAL FORCEP 30° 24/26FR CONTINUOUS FLOW INNER/OUTER SHEATH 23FR CYSTOSCOPE SHEATH ALBARRAN BRIDGE, SINGLE HORN RIGID OPTICAL FORCEP ADAPTER OUTER SHEATH HYSTEROSCOPE, 4MM 12DEG AUTOCLAVABLE SHEATH, 4MM DIAGNOSTIC OUTER ELLIK ADAPTER INNER SHEATH 17FR CYSTOSCOPE SHEATH 21FR URETHROTOME VISUAL OBTURATOR 4MM CYSTOSCOPE, KS SERIES 70DEG SIDE FIRE LASER INNR SHTH 4MM CYSTOSCOPE, KS SERIES 12DEG 4MM CANNULA WITH 1 FIXED STOPCOCK 24FR STANDARD FLOW RESECTOSCOPE SHEATH ADAPTER OBTURATOR, 2.9MM DIAGNOSTIC RIGID OPTICAL BIOPSY FORCEP 30° STONE CRUSHING FORCEP ADAPTER, OUTER SHEATH WORKING ELEMENT- PASSIVE (IGLESIAS) RIGID OPTICAL BIOPSY FORCEP 70° 17FR CYSTO VISUAL OBTURATOR DOUBLE HORN BRIDGE CYSTOSCOPE, 4MM 0 DEG AUTOCLAVABLE 25FR BALLOON CATHETER SHEATH 2.7MM HYSTERSCOPE OPERATIVE SHEATH (6MM DIAMETER) BLADDER SYRINGE ADAPTER, INNER SHEATH HYSTEROSCOPE, 2.9MM 12DEG 27/28FR RESECTOSCOPE VISUAL OBTURATOR 27/28FR CONTINUOUS FLOW INNER/OUTER SHEATH 19FR CYSTO STANDARD OBTURATOR 21FR CYSTO VISUAL OBTURATOR ELLIK ADAPTER OUTER SHEATH SHEATH, 4MM OPERATIVE OUTER URETHRAL DILATOR SET, CURVED (8FR-30FR) SWEEP GUIDE SIDE FIRE LASER SHEATH SHEATH, 2.9MM OPERATIVE OUTER OBTURATOR FOR 2.7MM DIAGNOSTIC HYSTEROSCOPE SHEATH EVALUATION BRIDGE REUSABLE STOPCOCK 2.8MM CANNULA WITH 2 FIXED STOPCOCKS COLD KNIFE, SERRATED 24/26FR RESECTOSCOPE TIMBERLAKE OBTURATOR 4MM HYSTERSCOPE DIAGNOSTIC SHEATH (6MM DIAMETER) VISUAL OBTURATOR, LASER CYSTOSCOPE RIGID OPTICAL FORCEP ADAPTER INNER SHEATH 24/26FR RESECTOSCOPE STANDARD OBTURATOR 27/28FR RESECTOSCOPE TIMBERLAKE OBTURATOR LASER BRIDGE (FOR USE WITH STRAIGHT FIRE LASER) URETHRAL DILATOR SET, STRAIGHT (8FR-30FR) RIGID OPTICAL GRASPING FORCEP 0°, 12° OBTURATOR, 4MM DIAGNOSTIC 24FR STANDARD FLOW RESECTOSCOPE SHEATH COLD KNIFE, HALF MOON CYSTOSCOPE, 4MM 12 DEG AUTOCLAVABLE ALBARRAN BRIDGE, DOUBLE HORN STANDARD OBTURATOR, 22/24FR RESECTOSCOPE 21FR VISUAL URETHROTOME SHEATH 25FR CYSTOSCOPE SHEATH Laparoscopes

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NWW Hysteroscope Accessories Obstetrics/Gynecology Class 1 884.1690 2018-02-28
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2015-06-12
FFD Evacuator, Bladder, Manually Operated Gastroenterology, Urology Class 1 876.4370 2018-11-22
KYW Container, Liquid Medication, Graduated General Hospital Class 1 880.6430 2011-05-30
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2025-07-09
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2013-04-15
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2023-06-13
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2018-06-14
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2018-06-14
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2018-06-14
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2019-07-01
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-12-09
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2026-06-17
GWG Endoscope, Neurological Neurology Class 2 882.1480 2026-06-17
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2025-07-09
EZO Urethrotome Gastroenterology, Urology Class 2 876.4770 2017-07-18
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2007-11-20
HRX Arthroscope Orthopedic Class 2 888.1100 2010-05-06
PPE Nephroscope Set Gastroenterology, Urology Class 2 876.1500 2019-01-11
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2017-07-28
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2017-07-28
FDC Resectoscope, Working Element Gastroenterology, Urology Class 2 876.1500 2017-07-28
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2010-11-18
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2008-10-10
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2019-04-23
KCP Syringe, Ent Ear, Nose, Throat Class 1 874.5220 1986-06-11
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2015-06-12
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2016-04-14
FMF Syringe, Piston General Hospital Class 2 880.5860 2008-10-15
HRX Arthroscope Orthopedic Class 2 888.1100 2007-11-20
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2013-04-15
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2016-04-11
HRX Arthroscope Orthopedic Class 2 888.1100 2010-05-20
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2017-08-31
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-04-11
HRX Arthroscope Orthopedic Class 2 888.1100 2020-08-30
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2025-07-09
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2007-11-20
HRX Arthroscope Orthopedic Class 2 888.1100 2019-03-06
HRX Arthroscope Orthopedic Class 2 888.1100 2017-07-28
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 1999-10-12
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2007-11-20
HRX Arthroscope Orthopedic Class 2 888.1100 2025-07-09
HRX Arthroscope Orthopedic Class 2 888.1100 2013-04-15
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2018-05-15
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2018-05-15
FFL Dislodger, Stone, Basket, Ureteral, Metal Gastroenterology, Urology Class 2 876.4680 2024-07-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-08-01
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2015-06-12
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2017-08-31
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2013-04-15
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2017-07-28
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2013-04-15
KQT Evacuator, Gastro-Urology Gastroenterology, Urology Class 2 876.4370 2013-04-15
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2013-04-15
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2013-04-15
KMA Irrigator, Powered Nasal Ear, Nose, Throat Class 1 874.5550 2022-01-19
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2020-08-30

Official Correspondent

No official correspondent registered.

US Agent Details

Lisa Liberty Email: Lisa.Liberty@hswoa.com Phone: (508) 6719377

Related Public Records

Same Entity

HENKE-SASS WOLF, GMBH.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
1222997 HENKE SASS WOLF OF AMERICA, INC. DUDLEY, MA, US
9515015 XION GmbH Berlin, DE

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
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
K961841 C.R. Bard, Inc. BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06) 1996-10-09
K851170 The Huxley Instrument Corp. DISSECTING TWEEZER #283-72PCS. SS 410 1985-04-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
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 8010418. Last updated year: 2026. Please use registration number 8010418 when referencing this establishment in official correspondence.
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