FDA Registration Active 🇩🇪 Germany

RIGID OPTICAL FORCEP ADAPTER INNER SHEATH

Reg #: 8010418 · FEI: 3007130719 · Expires 2025
Products
4
Proprietary Names
109
Establishment Types
1
Classifications
4

Registration Details

Registration Name
HENKE-SASS WOLF, GMBH.
Registration Number
8010418
FEI Number
3007130719
Status
Active
Expiry Year
2025
Initial Importer
No
Address
KELTENSTRASSE 1
City
TUTTLINGEN Baden-Wurttemberg
Country
DE

Regulatory Submissions

510(k) Number
K040390

Owner / Operator

Firm Name
HENKE-SASS WOLF, GMBH.
Operator Number
8010418
Address
Keltenstrasse 1, --
City
TUTTLINGEN
State
Baden-Wurttemberg
Postal Code
D-78532
Country
DE
Correspondent
MICHAEL - HERZOG

US Agent

Business Name
HENKE-SASS, WOLF OF AMERICA
Contact Name
Loretta MCHUGH
Address
135 SCHOFIELD AVENUE
City
Dudley
State
MA
ZIP
01571
Country
US
Phone
508 6719356

Products

Device Name Product Code
Electrode, Electrosurgical, Active, Urological FAS
Evacuator, Gastro-Urology KQT
Cystoscope And Accessories, Flexible/Rigid FAJ
Hysteroscope (And Accessories) HIH

Proprietary Names

RIGID OPTICAL FORCEP ADAPTER INNER SHEATH HYSTEROSCOPE, 2.9MM 30DEG SHEATH, 2.9MM DIAGNOSTIC INNER SIDE FIRE LASER OUTER SHTH 21FR CYSTO VISUAL OBTURATOR LASER BRIDGE (FOR USE WITH STRAIGHT FIRE LASER) SHEATH, 22/24FR RESECTOSCOPE INNER RIGID OPTICAL BIOPSY FORCEP 30° 19FR CYSTO STANDARD OBTURATOR STONE CRUSHING FORCEP ADAPTER, OUTER SHEATH 4MM HYSTERSCOPE OPERATIVE SHEATH (7MM DIAMETER) 17FR CYSTOSCOPE SHEATH SINGLE HORN BRIDGE 27/28FR RESECTOSCOPE STANDARD OBTURATOR RIGID OPTICAL STENT REMOVAL FORCEP 30° 24/26FR CONTINUOUS FLOW INNER/OUTER SHEATH SHEATH, 4MM DIAGNOSTIC INNER 27/28FR CONTINUOUS FLOW INNER/OUTER SHEATH HTA SCOPE BRIDGE ALBARRAN BRIDGE, SINGLE HORN CYSTOSCOPE, 4MM 30 DEG AUTOCLAVABLE 24/26FR RESECTOSCOPE VISUAL OBTURATOR 2.7MM HYSTERSCOPE OPERATIVE SHEATH (6MM DIAMETER) BLADDER SYRINGE ADAPTER, INNER SHEATH CYSTOSCOPE, 4MM 12 DEG AUTOCLAVABLE BLADDER SYRINGE ADAPTER, OUTER SHEATH SHEATH, 2.9MM DIAGNOSTIC OUTER 17FR CYSTO STANDARD OBTURATOR 21FR CYSTOSCOPE SHEATH SHEATH, 4MM OPERATIVE INNER COLD KNIFE, HOOK SIDE FIRE LASER INNR SHTH HYSTEROSCOPE, 4MM 30DEG AUTOCLAVABLE RIGID OPTICAL FORCEP ADAPTER OUTER SHEATH COLD KNIFE, SERRATED 27FR STANDARD FLOW RESECTOSCOPE SHEATH 4MM HYSTERSCOPE DIAGNOSTIC SHEATH (6MM DIAMETER) CYSTOSCOPE, 4MM 70 DEG AUTOCLAVABLE COLD KNIFE, HALF MOON 25FR BALLOON CATHETER SHEATH PORT SEAL HYSTEROSCOPE, 2.9MM 12DEG SHEATH, 22/24FR RESECTOSCOPE OUTER OBTURATOR, 4MM OPERATIVE 21FR CYSTO STANDARD OBTURATOR 27/28FR RESECTOSCOPE VISUAL OBTURATOR ELLIK ADAPTER INNER SHEATH 4MM CYSTOSCOPE, KS SERIES 30DEG RIGID OPTICAL BIOPSY FORCEP 0°, 12° CYSTOSCOPE, 4MM 30 DEG WITH GREEN LIGHT FILTER AUTOCLAVABLE SHEATH, 2.9MM OPERATIVE INNER WORKING ELEMENT- PASSIVE (IGLESIAS) OBTURATOR FOR 2.7MM DIAGNOSTIC HYSTEROSCOPE SHEATH SHEATH, 4MM DIAGNOSTIC OUTER 2.8MM CANNULA WITH 2 FIXED STOPCOCKS ELLIK ADAPTER CYSTO SHEATH STANDARD OBTURATOR, 22/24FR RESECTOSCOPE 21FR VISUAL URETHROTOME SHEATH 27FR STANDARD FLOW RESECTOSCOPE SHEATH ADAPTER 4MM CANNULA WITH 1 FIXED STOPCOCK 25FR CYSTOSCOPE SHEATH RIGID OPTICAL STONE CRUSHING FORCEP 30° 17FR CYSTO VISUAL OBTURATOR RIGID OPTICAL GRASPING FORCEP 0°, 12° DOUBLE HORN BRIDGE CYSTOSCOPE, 4MM 0 DEG AUTOCLAVABLE 21FR URETHROTOME STANDARD OBTURATOR COLD KNIFE, STRAIGHT 24/26FR RESECTOSCOPE TIMBERLAKE OBTURATOR VISUAL OBTURATOR, LASER CYSTOSCOPE HYSTEROSCOPE, 2.9MM 0DEG 25FR CYSTO VISUAL OBTURATOR 24FR STANDARD FLOW RESECTOSCOPE SHEATH 23FR CYSTO VISUAL OBTURATOR 25FR VISUAL URETHROTOME OUTER SHEATH HYSTEROSCOPE, 4MM 0DEG AUTOCLAVABLE 4MM CYSTOSCOPE, KS SERIES 0DEG 24FR STANDARD FLOW RESECTOSCOPE SHEATH ADAPTER 23FR CYSTOSCOPE SHEATH 4MM CYSTOSCOPE, KS SERIES 12DEG OBTURATOR, 2.9MM OPERATIVE COLD KNIFE, LOOP WORKING ELEMENT- ACTIVE (BAUMRUCKER) 25FR CYSTO STANDARD OBTURATOR 19FR CYSTOSCOPE SHEATH 24/26FR RESECTOSCOPE STANDARD OBTURATOR 27/28FR RESECTOSCOPE TIMBERLAKE OBTURATOR 23FR CYSTO STANDARD OBTURATOR ELLIK EVACUATOR SHEATH, 4MM OPERATIVE OUTER 21FR URETHROTOME VISUAL OBTURATOR BLADDER SYRINGE ADAPTER CYSTO SHEATH 4MM CYSTOSCOPE, KS SERIES 70DEG ELLIK ADAPTER OUTER SHEATH 21FR VISUAL URETHROTOME OPTICAL BRIDGE ALBARRAN BRIDGE, DOUBLE HORN OBTURATOR, 2.9MM DIAGNOSTIC HTA ADAPTER, 2.9MM HYSTEROSCOPE OBTURATOR, 4MM DIAGNOSTIC URETHRAL DILATOR SET, CURVED (8FR-30FR) SWEEP GUIDE SIDE FIRE LASER SHEATH RIGID OPTICAL BIOPSY FORCEP 70° URETHRAL DILATOR SET, STRAIGHT (8FR-30FR) WORKING ELEMENT, 22/24FR RESECTOSCOPE EVALUATION BRIDGE 19FR CYSTO VISUAL OBTURATOR SHEATH, 2.9MM OPERATIVE OUTER HYSTEROSCOPE, 4MM 12DEG AUTOCLAVABLE REUSABLE STOPCOCK

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)