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Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
FAD
Stent, Ureteral
2
Product Code
EXX
Probe, Rectal, Non-Powered
1
Product Code
EYD
Stirrups
1
Product Code
EYH
Table, Cysto, Non-Electrical
1
Product Code
EYS
Ribdam
1
Product Code
EZO
Urethrotome
2
Product Code
EZP
Rod, Colostomy
2
Product Code
FAR
Unit, Electrosurgical
2
Product Code
FAS
Electrode, Electrosurgical, Active, Urological
2
Product Code
FBJ
Cord, Electric For Transurethral Surgical Instrument
2
Product Code
FBS
Sound, Metal, Interconnected
1
Product Code
FCH
Tray, Biopsy, Without Biopsy Instruments
1
Product Code
FCS
Light, Catheter, Fiberoptic, Glass, Ureteral
2
Product Code
FDB
Plate, Patient
2
Product Code
FDG
Retractor, Fiberoptic
1
Product Code
FDI
Snare, Flexible
2
Product Code
FDJ
Snare, Rigid Self-Opening
2
Product Code
FDL
Wristlet, Patient Return
2
Product Code
FEH
Electrode, Flexible Suction Coagulator
2
Product Code
FEO
Lithotriptor, Ultrasonic
2
Product Code
K
23
0893
Swiss LthoClast Trilogy
2
Cleared 510(K)
K
18
2490
Swiss LithoClast Trilogy
2
Cleared 510(K)
K
18
1997
Swiss LithoClast Trilogy
2
Cleared 510(K)
K
18
1364
Swiss LithoClast Trilogy
2
Cleared 510(K)
K
17
3234
Swiss LithoClast Trilogy
2
Cleared 510(K)
K
17
1024
ShockPulse-SE Lithotripsy System
2
Cleared 510(K)
K
14
2428
Shock Pulse-SE Lithotripsy System CYBERWAND II
2
Cleared 510(K)
K
99
3046
FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000
2
Cleared 510(K)
K
97
3251
KSEA CALCUSON
2
Cleared 510(K)
K
92
0235
ULTRASOUND GENERATOR MODLE 2270
2
Cleared 510(K)
K
87
3367
OLYMPUS LUS ULTRASONIC LITHOTRIPTER
2
Cleared 510(K)
K
85
0298
ULTRALITH ULTRASONIC LITHOTRIPSY SYSTEM
2
Cleared 510(K)
K
84
3101
KARL STORZ 27086KC ULTRASONIC LITHOTRI
2
Cleared 510(K)
K
84
2024
ULTRASONIC LITHOTRIPTOR 300A
2
Cleared 510(K)
FFD
Evacuator, Bladder, Manually Operated
1
Product Code
FFE
System, Water Jet Catheter, Renal
2
Product Code
FFI
System, Alarm, Electrosurgical
2
Product Code
FFK
Lithotriptor, Electro-Hydraulic
2
Product Code
FFL
Dislodger, Stone, Basket, Ureteral, Metal
2
Product Code
FFN
Clamp, Non-Electrical
1
Product Code
FFO
Retractor, Self-Retaining
1
Product Code
FFQ
Speculum, Rectal
1
Product Code
FFR
Device, Locking, For Intestinal Clamp
1
Product Code
FGK
Tripsor, Stone, Bladder
2
Product Code
FGM
Probe And Director, Gastro-Urology
1
Product Code
FGN
Retractor, Non-Self-Retaining
1
Product Code
FGO
Dislodger, Stone, Flexible
2
Product Code
FGW
Clamp, Electrical
2
Product Code
FGX
Snare, Non-Electrical
1
Product Code
FHB
Hook, Gastro-Urology
1
Product Code
FHC
Adaptor To The Cord, For Transurethral Surgical Instrument
2
Product Code
FHF
System, Evacuator, Fluid
2
Product Code
FHH
Crusher, Spur, Colostomy
1
Product Code
FHI
Ring, Laparotomy
1
Product Code
FHK
Spreader, Bladder Neck
1
Product Code
FHL
Scoop
1
Product Code
FHN
Ligator, Hemorrhoidal
2
Product Code
FHQ
Holder, Needle, Gastroenterologic
1
Product Code
FHY
Jelly, Contact, For Transurethral Surgical Instrument
2
Product Code
FHZ
Desiccator, Transurethral
2
Product Code
FKK
Clamp, Line
1
Product Code
KGE
Forceps, Biopsy, Electric
2
Product Code
KNS
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
2
Product Code
KOA
Surgical Instruments, G-U, Manual (And Accessories)
1
Product Code
KQS
Table, Cystometric, Non-Electric And Accessories
1
Product Code
KQT
Evacuator, Gastro-Urology
2
Product Code
LQC
Lithotriptor, Biliary Mechanical
2
Product Code
MMZ
Table, Cystometric, Electric
2
Product Code
MND
Ligator, Esophageal
2
Product Code
NLR
Unit, Electrosurgical, Endoscopic (With Or Without Accessories), Reprocessed
2
Product Code
NLT
Snare, Flexible, Reprocessed
2
Product Code
NLU
Forceps, Biopsy, Electric, Reprocessed
2
Product Code
NLV
Electrode, Flexible Suction Coagulator, Reprocessed
2
Product Code
NLW
Electrode, Electrosurgical, Active, Urological, Reprocessed
2
Product Code
NQT
Dislodger, Stone, Flexible, Ureteral, Reprocessed
2
Product Code
NQU
Dislodger, Stone, Basket, Ureteral, Metal, Reprocessed
2
Product Code
NWI
Electrosurgical Electrode Kit
2
Product Code
OLH
Orchidometer
1
Product Code
ONJ
Dissolvable Gel For Preventing Ureteral Stone Migration
2
Product Code
OOW
Applicator For Rectal Suppository
1
Product Code
PKL
Hemostatic Metal Clip For The Gi Tract
2
Product Code
PLP
High Intensity Ultrasound System For Prostate Tissue Ablation
2
Product Code
PRU
Gastric Lavage Kit (Adult Or Pediatric Use)
2
Product Code
QGB
Ureteral Stent Accessories
1
Product Code
PVY
Vasovasostomy Set
1
Product Code
QNE
Endoscopic Pancreatic Debridement Device
2
Product Code
QAG
Endoscopic Electrosurgical Clip Cutting System
2
Product Code
LNK
Laser For Gastro-Urology Use
2
Product Code
MUK
Electrosurgical Radiofrequency System, Stress Urinary Incontinence, Female, Transvaginal Or Laparoscopic, Pelvic Tissue
2
Product Code
NEJ
System, Cryosurgical, Liquid Nitrogen, For Gastroenterology
2
Product Code
PZP
Fluid Jet Removal System
2
Product Code
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Review Panel
Last synced on 17 January 2025 at 11:05 pm
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subpart-e—surgical-devices
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FEO
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K843101
View Source
KARL STORZ 27086KC ULTRASONIC LITHOTRI
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K843101
510(k) Type
Traditional
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/11/1984
Days to Decision
126 days