FDA Registration
Active
🇳🇱 Netherlands
SHEATH, 22/24FR RESECTOSCOPE INNER
Reg #: 3008837339
·
FEI: 3008837339
·
Expires 2025
Products
4
Proprietary Names
176
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- STRYKER EMEA Supply Chain Services
- Registration Number
- 3008837339
- FEI Number
- 3008837339
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Frans Maasweg 2
- City
- Venlo Limburg
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K040390
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Evacuator, Gastro-Urology | KQT | Class 2 | Gastroenterology, Urology | No | 2008-01-25 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2008-01-25 |
| Hysteroscope (And Accessories) | HIH | Class 2 | Obstetrics/Gynecology | No | 2008-01-25 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2008-01-25 |
Proprietary Names
SHEATH, 22/24FR RESECTOSCOPE INNER
19FR CYSTO STANDARD OBTURATOR
STANDARD OBTURATOR, 22/24FR RESECTOSCOPE
5FR DOMED ELECTRODE, 65CM (3BX)
HTA ADAPTER, 2.9MM HYSTEROSCOPE
24FR., COLLINGS KNIFE ELECTRODE
23FR CYSTOSCOPE SHEATH
WORKING ELEMENT- ACTIVE (BAUMRUCKER)
HYSTEROSCOPE, 4MM 30DEG AUTOCLAVABLE
RIGID OPTICAL BIOPSY FORCEP 0°, 12°
25FR CYSTO STANDARD OBTURATOR
25FR CYSTO VISUAL OBTURATOR
3FR 3-WIRE GRASPING FORCEP, 70CM
22FR., VAPORIZATION ELECTRODE
RIGID OPTICAL STONE CRUSHING FORCEP 30°
SIDE FIRE LASER OUTER SHTH
2FR SHORT TIP ELECTRODE, 115CM (3BX)
24FR., ROLLER BALL ELECTRODE, 3.3MM
SIDE FIRE LASER INNR SHTH
FLEXIBLE SCISSOR, 5FR
4MM CANNULA WITH 1 FIXED STOPCOCK
BLADDER SYRINGE ADAPTER, INNER SHEATH
25FR BALLOON CATHETER SHEATH
OBTURATOR FOR 2.7MM DIAGNOSTIC HYSTEROSCOPE SHEATH
CYSTOSCOPE, 4MM 70 DEG AUTOCLAVABLE
ALBARRAN BRIDGE, DOUBLE HORN
19FR CYSTOSCOPE SHEATH
22 FR, COLLINGS KNIFE ELECTRODE
3FR FLEXIBLE GRASPING FORCEP, 60CM
CYSTOSCOPE, 4MM 30 DEG WITH GREEN LIGHT FILTER AUTOCLAVABLE
OBTURATOR, 2.9MM OPERATIVE
SCISSORS, 7FR SEMI FLEX
PORT SEAL
URETHRAL DILATOR SET, STRAIGHT (8FR-30FR)
5FR BUGBEE ELECTRODE, 65CM (3BX)
FLEXIBLE GRASPING FORCEP, 9FR
24FR., 90° CUTTING LOOP ELECTRODE, 14
SCISSORS, 5FR SEMI FLEX
24/26FR RESECTOSCOPE STANDARD OBTURATOR
27FR STANDARD FLOW RESECTOSCOPE SHEATH ADAPTER
21FR URETHROTOME STANDARD OBTURATOR
2FR LONG TIP ELECTRODE, 115CM (3BX)
24FR., SPIKE ELECTRODE
24FR STANDARD FLOW RESECTOSCOPE SHEATH
COLD KNIFE, HOOK
5FR BALL ELECTRODE, 65CM (3BX)
FLEXIBLE BIOPSY FORCEP, CUP, 5FR
24FR., VAPORIZATION ELECTRODE
BIOPSY CUP 5FR SEMI FLEX
24/26FR RESECTOSCOPE VISUAL OBTURATOR
21FR URETHROTOME VISUAL OBTURATOR
3FR SHORT TIP ELECTRODE, 115CM (3BX)
FLEXIBLE GRASPING FORCEP, 5FR
24FR., 0° (STRAIGHT) CUTTING LOOP ELECTRODE, 14
GRASPER, 5FR SEMI FLEX
24FR STANDARD FLOW RESECTOSCOPE SHEATH ADAPTER
COLD KNIFE, LOOP
3FR 3-WIRE GRASPING FORCEP, 90CM
24FR., ROLLER ELECTRODE, 3MM
SWEEP GUIDE SIDE FIRE LASER SHEATH
SHEATH, 22/24FR RESECTOSCOPE OUTER
21FR CYSTOSCOPE SHEATH
FLEXIBLE BIOPSY FORCEP, CUP, 9FR
2.8MM CANNULA WITH 2 FIXED STOPCOCKS
LASER BRIDGE (FOR USE WITH STRAIGHT FIRE LASER)
25FR VISUAL URETHROTOME OUTER SHEATH
2.7MM HYSTERSCOPE OPERATIVE SHEATH (6MM DIAMETER)
22 FR, ROLLING BALL ELECTRODE
27FR., 30° CUTTING LOOP ELECTRODE, 14
SHEATH, 4MM OPERATIVE INNER
27/28FR RESECTOSCOPE VISUAL OBTURATOR
ELLIK ADAPTER INNER SHEATH
4MM CYSTOSCOPE, KS SERIES 12DEG
7FR BALL ELECTRODE, 40CM (3BX)
22FR., ROLLER BALL ELECTRODE, 303MM
27FR., ROLLER BALL ELECTRODE, 3.3MM
SHEATH, 4MM DIAGNOSTIC INNER
25FR CYSTOSCOPE SHEATH
24/26FR CONTINUOUS FLOW INNER/OUTER SHEATH
3FR LONG TIP ELECTRODE, 115CM (3BX)
FLEXIBLE GRASPING FORCEP, 7FR
24FR., 30° CUTTING LOOP ELECTRODE, 14
BIOPSY PUNCH 5FR SEMI FLE
27FR STANDARD FLOW RESECTOSCOPE SHEATH
21FR VISUAL URETHROTOME SHEATH
FLEXIBLE SCISSOR, 9FR
HYSTEROSCOPE, 2.9MM 12DEG
EVALUATION BRIDGE
RIGID OPTICAL BIOPSY FORCEP 30°
ELLIK ADAPTER CYSTO SHEATH
4MM HYSTERSCOPE OPERATIVE SHEATH (7MM DIAMETER)
WORKING ELEMENT, 22/24FR RESECTOSCOPE
HTA SCOPE BRIDGE
21FR CYSTO STANDARD OBTURATOR
WORKING ELEMENT- PASSIVE (IGLESIAS)
4MM CYSTOSCOPE, KS SERIES 0DEG
7FR BUGBEE ELECTRODE, 40CM (3BX)
22FR., ROLLER ELECTRODE, 3MM
27FR., ROLLER ELECTRODE, 3MM
23FR CYSTO STANDARD OBTURATOR
27/28FR RESECTOSCOPE TIMBERLAKE OBTURATOR
STRYKER UROLOGY AND GYN
22 FR, 30 DEGREE CUTTING LOOP ELECTRODE, 14
5FR FLEXIBLE BIOPSY CUP FORCEP, 60CM
27FR., 90° CUTTING LOOP ELECTRIC, 14
OBTURATOR, 2.9MM DIAGNOSTIC
SHEATH, 4MM OPERATIVE OUTER
COLD KNIFE, HALF MOON
ELLIK ADAPTER OUTER SHEATH
22 FR, 0 DEGREE (STRAIGHT) CUTTING LOOP ELECTRODE, 14
5FR FLEXIBLE SCISSOR, 60CM
27FR., VAPORIZATION ELECTRODE
SHEATH, 2.9MM DIAGNOSTIC INNER
GRSPR, 7FR SEMI-FLX SINGLACTION
COLD KNIFE, STRAIGHT
URETHRAL DILATOR SET, CURVED (8FR-30FR)
3FR FLEXIBLE BIOPSY CUP FORCEP 60CM
SHEATH, 2.9MM OPERATIVE INNER
BIOPSY CUP 7FR SEMI FLEX
ALBARRAN BRIDGE, SINGLE HORN
17FR CYSTO VISUAL OBTURATOR
22FR., COLLINGS KNIFE ELECTRODE
RIGID OPTICAL BIOPSY FORCEP 70°
VISUAL OBTURATOR, LASER CYSTOSCOPE
4MM CYSTOSCOPE, KS SERIES 70DEG
22FR., 30° CUTTING LOOP ELECTRODE, 14
OBTURATOR, 4MM DIAGNOSTIC
RIGID OPTICAL GRASPING FORCEP 0°, 12°
RIGID OPTICAL STENT REMOVAL FORCEP 30°
HYSTEROSCOPE, 4MM 12DEG AUTOCLAVABLE
RIGID OPTICAL FORCEP ADAPTER INNER SHEATH
23FR CYSTO VISUAL OBTURATOR
CYSTOSCOPE, 4MM 30 DEG AUTOCLAVABLE
DOUBLE HORN BRIDGE
17FR CYSTO STANDARD OBTURATOR
CYSTOSCOPE, 4MM 12 DEG AUTOCLAVABLE
FLEXIBLE BIOPSY FORCEP, CUP, 7FR
GRASPER 5 FR SEMI FLX DBLACTION
24/26FR RESECTOSCOPE TIMBERLAKE OBTURATOR
21FR VISUAL URETHROTOME OPTICAL BRIDGE
5FR FLEXIBLE GRASPING FORCEP, 60CM
HYSTEROSCOPE, 2.9MM 30DEG
SINGLE HORN BRIDGE
17FR CYSTOSCOPE SHEATH
CYSTOSCOPE, 4MM 0 DEG AUTOCLAVABLE
FLEXIBLE SCISSOR, 7FR
HYSTEROSCOPE, 2.9MM 0DEG
BLADDER SYRINGE ADAPTER, OUTER SHEATH
ELLIK EVACUATOR
4MM HYSTERSCOPE DIAGNOSTIC SHEATH (6MM DIAMETER)
22 FR, DIMPLED VAPORIZING ROLLER BALL ELECTRODE
5FR FLEXIBLE RAT TOOTH FORCEP, 60CM
27FR., COLLINGS KNIFE ELECTRODE
SHEATH, 2.9MM DIAGNOSTIC OUTER
BIOPSY PUNCH, 7FR. SEMI-FLEXIBLE
BLADDER SYRINGE ADAPTER CYSTO SHEATH
COLD KNIFE, SERRATED
REUSABLE STOPCOCK
4MM CYSTOSCOPE, KS SERIES 30DEG
7FR DOMED ELECTRODE, 40CM (3BX)
22FR., 30° (STRAIGHT) CUTTING LOOP ELECTRODE, 14
27FR., SPIKE ELECTRODE
SHEATH, 4MM DIAGNOSTIC OUTER
27/28FR RESECTOSCOPE STANDARD OBTURATOR
22 FR, GOLD COAGULATING ELECTRODE
27FR., 0 DEG (STRAIGHT) CUTTING LOOP ELECTRODE, 14
OBTURATOR, 4MM OPERATIVE
27/28FR CONTINUOUS FLOW INNER/OUTER SHEATH
HYSTEROSCOPE, 4MM 0DEG AUTOCLAVABLE
RIGID OPTICAL FORCEP ADAPTER OUTER SHEATH
21FR CYSTO VISUAL OBTURATOR
3FR FLEXIBLE RAT TOOTH FORCEP, 60CM
SHEATH, 2.9MM OPERATIVE OUTER
GRASPER, 7FR SEMI FL DOUBLE
STONE CRUSHING FORCEP ADAPTER, OUTER SHEATH
19FR CYSTO VISUAL OBTURATOR
Establishment Types
Export Device to the United States But Perform No Other Operation on Device