FDA Registration
Active
🇩🇪 Germany
RIGID OPTICAL FORCEP ADAPTER INNER SHEATH
Reg #: 3006855072
·
FEI: 3006855072
·
Expires 2025
Products
4
Proprietary Names
109
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Klaus Wenkert Medizintechnik GmbH
- Registration Number
- 3006855072
- FEI Number
- 3006855072
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Hohnerstrasse 24
- City
- Seitingen - Oberflacht 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
- [email protected]
- Phone
- 508 6719356
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2013-04-15 |
| Evacuator, Gastro-Urology | KQT | Class 2 | Gastroenterology, Urology | No | 2013-04-15 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2013-04-15 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2013-04-15 |
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)