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

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