FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
EQL
Laryngostroboscope
1
Product Code
EOQ
Bronchoscope (Flexible Or Rigid)
2
Product Code
EOX
Esophagoscope (Flexible Or Rigid)
2
Product Code
BST
Curette, Biopsy, Bronchoscope (Non-Rigid)
2
Product Code
BTG
Brush, Biopsy, Bronchoscope (Non-Rigid)
2
Product Code
BWH
Forceps, Biopsy, Bronchoscope (Non-Rigid)
2
Product Code
EMX
Balloon, Epistaxis
1
Product Code
ENW
Catheter, Nasopharyngeal
1
Product Code
ENZ
Telescope, Laryngeal-Bronchial
2
Product Code
EOB
Nasopharyngoscope (Flexible Or Rigid)
2
Product Code
EQH
Source, Carrier, Fiberoptic Light
1
Product Code
EQJ
Bur, Ear, Nose And Throat
1
Product Code
EQN
Laryngoscope, Nasopharyngoscope
2
Product Code
ERA
Otoscope
1
Product Code
ERL
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
2
Product Code
K
23
3958
hekaDrill
2
Cleared 510(K)
K
22
1184
ORiGO System
2
Cleared 510(K)
K
21
3221
AMADEO, M-UK1015 (incl. attachments and accessories)
2
Cleared 510(K)
K
21
2650
Celeris, Disposable Sinus Debrider
2
Cleared 510(K)
K
21
1490
Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
2
Cleared 510(K)
K
20
0318
UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece
2
Cleared 510(K)
K
19
0715
EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand
2
Cleared 510(K)
K
18
0063
OCM-G1 Attachment
2
Cleared 510(K)
K
17
1840
Stryker Consolidated Operating Room Equipment (CORE) 2 Console
2
Cleared 510(K)
K
16
3247
3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider
2
Cleared 510(K)
K
16
1376
DragonFly Surgical Drill System
2
Cleared 510(K)
K
16
1101
PolypVac Microdebrider (3.3mm and 4.0mm)
2
Cleared 510(K)
K
15
2744
DIEGO ELITE DRILL
2
Cleared 510(K)
K
15
0969
Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces
2
Cleared 510(K)
K
15
2641
Pi Drive Plus Motor, Extender
2
Cleared 510(K)
K
15
0728
XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole
2
Cleared 510(K)
K
14
3492
OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece
2
Cleared 510(K)
K
14
1935
STRYKER S2 DRILL
2
Cleared 510(K)
K
13
1053
ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM
2
Cleared 510(K)
K
13
3133
LAURIMED POLYPVAC MICRODEBRIDER
2
Cleared 510(K)
K
12
1678
DTAD
2
Cleared 510(K)
K
11
2593
STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
2
Cleared 510(K)
K
08
3720
OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K
2
Cleared 510(K)
K
08
1814
REPROCESSED ENT SHAVERS
2
Cleared 510(K)
K
08
0052
STRYKER ESSX WITH NAVIGATION MOUNT
2
Cleared 510(K)
K
08
0722
PRIMADO SURGICAL DRILL
2
Cleared 510(K)
K
08
1277
XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
2
Cleared 510(K)
K
07
3633
STRYKER ESSX MICRODEBRIDER SYSTEM
2
Cleared 510(K)
K
07
3255
XPS 3000 SYSTEM
2
Cleared 510(K)
K
05
3262
KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
2
Cleared 510(K)
K
04
1523
XPS 3000 SYSTEM
2
Cleared 510(K)
K
04
1413
XPS 3000 SYSTEM
2
Cleared 510(K)
K
04
0300
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
2
Cleared 510(K)
K
03
4004
DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
2
Cleared 510(K)
K
02
3070
SODEM HIGH SPEED SYSTEM (PNEUMATIC)
2
Cleared 510(K)
K
02
1098
DAUM-LECTRIC MRI DRILLING MACHINE
2
Cleared 510(K)
K
02
1811
UNIDRIVE II PLUS DISPOSABLE TUBING SET
2
Cleared 510(K)
K
02
0594
DIEGO POWERED DISSECTOR AND DRILL SYSTEM
2
Cleared 510(K)
K
01
2456
SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
2
Cleared 510(K)
K
01
1321
MODIFICATION TO XPS 3000 SYSTEM
2
Cleared 510(K)
K
01
1381
HUMMER IV MICRODEBRIDER SYSTEM
2
Cleared 510(K)
K
00
3994
KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
2
Cleared 510(K)
K
00
2224
XPS 3000 SYSTEM
2
Cleared 510(K)
K
00
2828
XPS NITRO SYSTEM
2
Cleared 510(K)
K
99
2994
TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS;
2
Cleared 510(K)
K
99
0038
HUMMER TRAK SYSTEM
2
Cleared 510(K)
K
98
3050
PNEUMATIC CUTTER SYSTEM
2
Cleared 510(K)
K
98
3224
XPS DRILL SYSTEM
2
Cleared 510(K)
K
98
1041
SLT BIPOLAR SHEATH
2
Cleared 510(K)
K
98
1637
INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY
2
Cleared 510(K)
K
97
4174
ULTRABUR
2
Cleared 510(K)
K
97
2057
POWERTREK INSTRUMENTS
2
Cleared 510(K)
K
97
2584
STRYKER HUMMER II MICRODEBRIDER SYSTEM
2
Cleared 510(K)
K
97
3286
ENT IRRIGATING PUMP (70327700)
2
Cleared 510(K)
K
97
2865
PROMEX ENT TISSUE REMOVAL SYSTEM
2
Cleared 510(K)
K
97
2453
XPS STRAIGHTSHOT MICRORESECTOR
2
Cleared 510(K)
K
97
0965
MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)
2
Cleared 510(K)
K
96
4548
APEX UNIVERSAL DRIVE SYSTEM
2
Cleared 510(K)
K
96
5080
ANSPACH MICROMAX SYSTEM
2
Cleared 510(K)
K
96
3246
TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT
2
Cleared 510(K)
K
96
2163
MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL
2
Cleared 510(K)
K
96
1192
IRRIGATION SYSTEM
2
Cleared 510(K)
K
95
4989
DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
2
Cleared 510(K)
K
95
4796
MICRO-INGRESSOR HANDIPIECE
2
Cleared 510(K)
K
95
4715
MICRO-PLANER HANDPIECE
2
Cleared 510(K)
K
95
2681
STRYKER HUMMER II MICRODEBRIDER SYSTEM
2
Cleared 510(K)
K
95
1263
INTRAARC DRIVE SYSTEM
2
Cleared 510(K)
K
95
0964
KARL STORZ INTRA-HANDPIECES AND ACCESSORIES
2
Cleared 510(K)
K
94
5659
BLACKSTAR(TM) STAR SYSTEM
2
Cleared 510(K)
K
94
3569
STRYKER TOTAL PERFORMANCE SYSTEM
2
Cleared 510(K)
K
94
5438
EDI-BUR MICRODRILL SYSTEMS
2
Cleared 510(K)
K
94
0016
ELECTRIC SURGICAL DRILL
2
Cleared 510(K)
K
94
4476
APEX UNIVERSAL DRIVE SYSTEM
2
Cleared 510(K)
K
94
3108
MEDNEXT MICRO-DRILL
2
Cleared 510(K)
K
94
0710
STRYKER MICRODEBRIDER SYSTEM
2
Cleared 510(K)
K
91
4346
DRILL MODULES MODELS 2116/2117
2
Cleared 510(K)
K
90
5800
X-T AIR DRILL
2
Cleared 510(K)
K
87
3154
TREACE MAGNUM OTO-TOOL SYSTEM
2
Cleared 510(K)
K
86
2807
TREACE DRILL SYSTEM
2
Cleared 510(K)
K
85
4332
MICRO-AIRE STAPES DRILL SYSTEM
2
Cleared 510(K)
K
85
4331
MICRO-AIRE OTO/NEURO DRILL SYSTEM
2
Cleared 510(K)
K
84
1813
TISSUE INTEGRATED PROSTHESIS DRILL
2
Cleared 510(K)
K
83
3874
SHEA MIDDLE EAR MICRODRILL
2
Cleared 510(K)
K
83
3875
SHEA FOOTPLATE MICRODRILL
2
Cleared 510(K)
K
83
1946
SURGICAL DRILL-ELECTRIC-HANDPIECE
2
Cleared 510(K)
K
82
2008
TORX OR TYPE MICRO MOTOR HANDPIECE
2
Cleared 510(K)
K
80
2463
MICRO-SURGICAL POWER INSTRUMENT SYSTEM
2
Cleared 510(K)
K
79
2159
FISCH DRILL SYSTEM
2
Cleared 510(K)
K
79
1407
WOMED NICRO-CRAFT POWER SYSTEM
2
Cleared 510(K)
K
78
1418
XOMED TRANSSPHENOIDAL HANDPIECE
2
Cleared 510(K)
EWG
Laser, Ent Microsurgical Carbon-Dioxide
2
Product Code
EWQ
Saw, Surgical, Ent (Electric Or Pneumatic)
1
Product Code
EWY
Mediastinoscope, Surgical
2
Product Code
JEI
Claw, Foreign Body, Bronchoscope (Non-Rigid)
2
Product Code
JEJ
Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)
2
Product Code
JEK
Forceps, Biopsy, Bronchoscope (Rigid)
2
Product Code
JEL
Curette, Biopsy, Bronchoscope (Rigid)
2
Product Code
JYE
Chisel, Middle-Ear
1
Product Code
JYF
Clamp, Ossicle Holding
1
Product Code
JYG
Curette, Ear
1
Product Code
JYH
Excavator, Ear
1
Product Code
JYI
Gauge, Mastoid
1
Product Code
JYJ
Gauge, Measuring
1
Product Code
JYL
Hook, Microsurgical Ear
1
Product Code
JYM
Inserter, Myringotomy Tube
1
Product Code
JYN
Inserter, Sacculotomy Tack
1
Product Code
JYO
Knife, Ear
1
Product Code
JYP
Knife, Myringotomy
1
Product Code
JYQ
Loop, Wire
1
Product Code
JYR
Nipper, Malleus
1
Product Code
JYS
Perforator, Ear-Lobe
1
Product Code
JYT
Pick, Microsurgical Ear
1
Product Code
JYW
Press, Vein
1
Product Code
JYX
Punch, Attic
1
Product Code
JYY
Rasp, Ear
1
Product Code
JYZ
Rod, Measuring Ear
1
Product Code
JZA
Rongeur, Mastoid
1
Product Code
JZB
Scissors, Ear
1
Product Code
JZC
Searcher, Mastoid
1
Product Code
JZD
Snare, Ear
1
Product Code
JZE
Spoon, Ear
1
Product Code
JZF
Tube, Ear Suction
1
Product Code
JZY
Knife, Laryngeal
1
Product Code
JZZ
Saw, Laryngeal
1
Product Code
KAA
Set, Laryngeal Injection
1
Product Code
KAB
Trocar, Laryngeal
1
Product Code
KAC
Tube, Laryngectomy
1
Product Code
KAD
Elevator, Ent
1
Product Code
KAE
Forceps, Ent
1
Product Code
KAH
Microrule, Ent
1
Product Code
KAI
Mirror, Ent
1
Product Code
KAJ
Mobilizer, Ent
1
Product Code
KAK
Probe, Ent
1
Product Code
KAL
Retractor, Ent
1
Product Code
KAO
Curette, Ethmoid
1
Product Code
KAP
Curette, Nasal
1
Product Code
KAQ
Gouge, Nasal, Ent
1
Product Code
KAR
Irrigator, Sinus
1
Product Code
KAS
Knife, Nasal
1
Product Code
KAT
Perforator, Antrum
1
Product Code
KAW
Punch, Antrum
1
Product Code
KAX
Punch, Ethmoid
1
Product Code
KAY
Punch, Nasal
1
Product Code
KAZ
Rasp, Frontal-Sinus
1
Product Code
KBA
Rasp, Nasal
1
Product Code
KBB
Rongeur, Nasal
1
Product Code
KBC
Saw, Nasal
1
Product Code
KBD
Scissors, Nasal
1
Product Code
KBE
Snare, Nasal
1
Product Code
KBF
Trephine, Sinus
1
Product Code
KBG
Trocar, Sinus
1
Product Code
KBH
Adenotome
1
Product Code
KBI
Bougie, Eustachian
1
Product Code
KBJ
Curette, Adenoid
1
Product Code
KBK
Curette, Salpingeal
1
Product Code
KBL
Depressor, Metal Tongue, Surgical
1
Product Code
KBM
Dissector, Tonsil
1
Product Code
KBN
Gag, Mouth
1
Product Code
KBO
Guillotine, Tonsil
1
Product Code
KBP
Hook, Tonsil Suturing
1
Product Code
KBQ
Knife, Tonsil
1
Product Code
KBR
Needle, Tonsil Suturing
1
Product Code
KBS
Punch, Adenoid
1
Product Code
KBT
Punch, Tonsil
1
Product Code
KBW
Screw, Oral
1
Product Code
KBX
Screw, Tonsil
1
Product Code
KBY
Set, Filliform, Eustachian
1
Product Code
KBZ
Snare, Tonsil
1
Product Code
KCA
Tonsillectome
1
Product Code
KCB
Tube, Tonsil Suction
1
Product Code
KCC
Bistoury, Tracheal
1
Product Code
KCD
Bougie, Esophageal, Ent
1
Product Code
KCF
Dilator, Esophageal, Ent
1
Product Code
KCG
Dilator, Tracheal
1
Product Code
KCH
Hook, Tracheal
1
Product Code
KCI
Trocar, Tracheal
1
Product Code
KTE
Trocar, Ent
1
Product Code
KTF
Punch, Ent
1
Product Code
KTG
Knife, Ent
1
Product Code
KTI
Bronchoscope Accessory
2
Product Code
KTR
Tube, Aspirating, Bronchoscope, Rigid
2
Product Code
LJW
Tracheotome
1
Product Code
LMS
Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
2
Product Code
LRC
Instrument, Ent Manual Surgical
1
Product Code
LXR
Laser, Microsurgical Argon, For Use In Otology
2
Product Code
LYA
Splint, Intranasal Septal
1
Product Code
MMO
Tray, Surgical, Ent
1
Product Code
MQW
Transilluminator, Fiber Optic
1
Product Code
MXP
Bone Particle Collector
1
Product Code
NLB
Trocar, Tracheal, Laryngeal, Sinus, Reprocessed
1
Product Code
NLE
Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed
2
Product Code
NLY
Microdebrider, Ent, High Speed, Single Use, Reprocessed
1
Product Code
NLZ
Bur, Ent, Diamond Coated, Single Use, Reprocessed
1
Product Code
OGR
Ear, Nose, And Throat Surgical Tray
1
Product Code
OGU
Pierced Ear/Entry Cleaning Tray
1
Product Code
PNZ
Eustachian Tube Balloon Dilation Device
2
Product Code
QGK
Balloon, Nasal Airway
1
Product Code
QJL
Splint, Intranasal Septal, Cber Led
1
Product Code
QNW
Reprocessed Bronchoscope
2
Product Code
QQH
Powered Insertion System For A Cochlear Implant Electrode Array
2
Product Code
OLL
Septal Stapler/Absorbable Staples
2
Product Code
SBS
Laryngeal Injection Set With Led Light
1
Product Code
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—General Hospital and Personal Use Miscellaneous Devices
CFR Sub-Part
Subpart G—Miscellaneous Devices
CFR Sub-Part
Gastroenterology and Urology
Review Panel
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Hematology
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Immunology
Review Panel
Microbiology
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Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
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Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
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Review Panel
Medical Genetics
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Review Panel
Last synced on 13 December 2024 at 11:05 pm
EN
/
subpart-e—surgical-devices
/
ERL
/
K781418
View Source
XOMED TRANSSPHENOIDAL HANDPIECE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K781418
510(k) Type
Traditional
Applicant
XOMED, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/31/1978
Days to Decision
15 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Miscellaneous
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
EQL
Laryngostroboscope
EOQ
Bronchoscope (Flexible Or Rigid)
EOX
Esophagoscope (Flexible Or Rigid)
BST
Curette, Biopsy, Bronchoscope (Non-Rigid)
BTG
Brush, Biopsy, Bronchoscope (Non-Rigid)
BWH
Forceps, Biopsy, Bronchoscope (Non-Rigid)
EMX
Balloon, Epistaxis
ENW
Catheter, Nasopharyngeal
ENZ
Telescope, Laryngeal-Bronchial
EOB
Nasopharyngoscope (Flexible Or Rigid)
EQH
Source, Carrier, Fiberoptic Light
EQJ
Bur, Ear, Nose And Throat
EQN
Laryngoscope, Nasopharyngoscope
ERA
Otoscope
ERL
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
K
23
3958
hekaDrill
K
22
1184
ORiGO System
K
21
3221
AMADEO, M-UK1015 (incl. attachments and accessories)
K
21
2650
Celeris, Disposable Sinus Debrider
K
21
1490
Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000
K
20
0318
UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece
K
19
0715
EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand
K
18
0063
OCM-G1 Attachment
K
17
1840
Stryker Consolidated Operating Room Equipment (CORE) 2 Console
K
16
3247
3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider
K
16
1376
DragonFly Surgical Drill System
K
16
1101
PolypVac Microdebrider (3.3mm and 4.0mm)
K
15
2744
DIEGO ELITE DRILL
K
15
0969
Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces
K
15
2641
Pi Drive Plus Motor, Extender
K
15
0728
XPS Nexus System, XPS Nexus Foot Control, XPS Nexus IV Pole
K
14
3492
OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece
K
14
1935
STRYKER S2 DRILL
K
13
1053
ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM
K
13
3133
LAURIMED POLYPVAC MICRODEBRIDER
K
12
1678
DTAD
K
11
2593
STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K
08
3720
OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K
K
08
1814
REPROCESSED ENT SHAVERS
K
08
0052
STRYKER ESSX WITH NAVIGATION MOUNT
K
08
0722
PRIMADO SURGICAL DRILL
K
08
1277
XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
K
07
3633
STRYKER ESSX MICRODEBRIDER SYSTEM
K
07
3255
XPS 3000 SYSTEM
K
05
3262
KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
K
04
1523
XPS 3000 SYSTEM
K
04
1413
XPS 3000 SYSTEM
K
04
0300
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
K
03
4004
DIEGO RF POWERED DISSECTOR AND DRILL SYSTEM CONSOLE
K
02
3070
SODEM HIGH SPEED SYSTEM (PNEUMATIC)
K
02
1098
DAUM-LECTRIC MRI DRILLING MACHINE
K
02
1811
UNIDRIVE II PLUS DISPOSABLE TUBING SET
K
02
0594
DIEGO POWERED DISSECTOR AND DRILL SYSTEM
K
01
2456
SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
K
01
1321
MODIFICATION TO XPS 3000 SYSTEM
K
01
1381
HUMMER IV MICRODEBRIDER SYSTEM
K
00
3994
KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES
K
00
2224
XPS 3000 SYSTEM
K
00
2828
XPS NITRO SYSTEM
K
99
2994
TURBO 7000 SHAVER AND DRILL CONSOLE; TURBO 7000 HANDPIECES; ESSENTIAL SHAVER/BURRS;
K
99
0038
HUMMER TRAK SYSTEM
K
98
3050
PNEUMATIC CUTTER SYSTEM
K
98
3224
XPS DRILL SYSTEM
K
98
1041
SLT BIPOLAR SHEATH
K
98
1637
INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY
K
97
4174
ULTRABUR
K
97
2057
POWERTREK INSTRUMENTS
K
97
2584
STRYKER HUMMER II MICRODEBRIDER SYSTEM
K
97
3286
ENT IRRIGATING PUMP (70327700)
K
97
2865
PROMEX ENT TISSUE REMOVAL SYSTEM
K
97
2453
XPS STRAIGHTSHOT MICRORESECTOR
K
97
0965
MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)
K
96
4548
APEX UNIVERSAL DRIVE SYSTEM
K
96
5080
ANSPACH MICROMAX SYSTEM
K
96
3246
TREBAY MICRODEBRIDER OR XPS STRAIGHT SHOT
K
96
2163
MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL
K
96
1192
IRRIGATION SYSTEM
K
95
4989
DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES
K
95
4796
MICRO-INGRESSOR HANDIPIECE
K
95
4715
MICRO-PLANER HANDPIECE
K
95
2681
STRYKER HUMMER II MICRODEBRIDER SYSTEM
K
95
1263
INTRAARC DRIVE SYSTEM
K
95
0964
KARL STORZ INTRA-HANDPIECES AND ACCESSORIES
K
94
5659
BLACKSTAR(TM) STAR SYSTEM
K
94
3569
STRYKER TOTAL PERFORMANCE SYSTEM
K
94
5438
EDI-BUR MICRODRILL SYSTEMS
K
94
0016
ELECTRIC SURGICAL DRILL
K
94
4476
APEX UNIVERSAL DRIVE SYSTEM
K
94
3108
MEDNEXT MICRO-DRILL
K
94
0710
STRYKER MICRODEBRIDER SYSTEM
K
91
4346
DRILL MODULES MODELS 2116/2117
K
90
5800
X-T AIR DRILL
K
87
3154
TREACE MAGNUM OTO-TOOL SYSTEM
K
86
2807
TREACE DRILL SYSTEM
K
85
4332
MICRO-AIRE STAPES DRILL SYSTEM
K
85
4331
MICRO-AIRE OTO/NEURO DRILL SYSTEM
K
84
1813
TISSUE INTEGRATED PROSTHESIS DRILL
K
83
3874
SHEA MIDDLE EAR MICRODRILL
K
83
3875
SHEA FOOTPLATE MICRODRILL
K
83
1946
SURGICAL DRILL-ELECTRIC-HANDPIECE
K
82
2008
TORX OR TYPE MICRO MOTOR HANDPIECE
K
80
2463
MICRO-SURGICAL POWER INSTRUMENT SYSTEM
K
79
2159
FISCH DRILL SYSTEM
K
79
1407
WOMED NICRO-CRAFT POWER SYSTEM
K
78
1418
XOMED TRANSSPHENOIDAL HANDPIECE
EWG
Laser, Ent Microsurgical Carbon-Dioxide
EWQ
Saw, Surgical, Ent (Electric Or Pneumatic)
EWY
Mediastinoscope, Surgical
JEI
Claw, Foreign Body, Bronchoscope (Non-Rigid)
JEJ
Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)
JEK
Forceps, Biopsy, Bronchoscope (Rigid)
JEL
Curette, Biopsy, Bronchoscope (Rigid)
JYE
Chisel, Middle-Ear
JYF
Clamp, Ossicle Holding
JYG
Curette, Ear
JYH
Excavator, Ear
JYI
Gauge, Mastoid
JYJ
Gauge, Measuring
JYL
Hook, Microsurgical Ear
JYM
Inserter, Myringotomy Tube
JYN
Inserter, Sacculotomy Tack
JYO
Knife, Ear
JYP
Knife, Myringotomy
JYQ
Loop, Wire
JYR
Nipper, Malleus
JYS
Perforator, Ear-Lobe
JYT
Pick, Microsurgical Ear
JYW
Press, Vein
JYX
Punch, Attic
JYY
Rasp, Ear
JYZ
Rod, Measuring Ear
JZA
Rongeur, Mastoid
JZB
Scissors, Ear
JZC
Searcher, Mastoid
JZD
Snare, Ear
JZE
Spoon, Ear
JZF
Tube, Ear Suction
JZY
Knife, Laryngeal
JZZ
Saw, Laryngeal
KAA
Set, Laryngeal Injection
KAB
Trocar, Laryngeal
KAC
Tube, Laryngectomy
KAD
Elevator, Ent
KAE
Forceps, Ent
KAH
Microrule, Ent
KAI
Mirror, Ent
KAJ
Mobilizer, Ent
KAK
Probe, Ent
KAL
Retractor, Ent
KAO
Curette, Ethmoid
KAP
Curette, Nasal
KAQ
Gouge, Nasal, Ent
KAR
Irrigator, Sinus
KAS
Knife, Nasal
KAT
Perforator, Antrum
KAW
Punch, Antrum
KAX
Punch, Ethmoid
KAY
Punch, Nasal
KAZ
Rasp, Frontal-Sinus
KBA
Rasp, Nasal
KBB
Rongeur, Nasal
KBC
Saw, Nasal
KBD
Scissors, Nasal
KBE
Snare, Nasal
KBF
Trephine, Sinus
KBG
Trocar, Sinus
KBH
Adenotome
KBI
Bougie, Eustachian
KBJ
Curette, Adenoid
KBK
Curette, Salpingeal
KBL
Depressor, Metal Tongue, Surgical
KBM
Dissector, Tonsil
KBN
Gag, Mouth
KBO
Guillotine, Tonsil
KBP
Hook, Tonsil Suturing
KBQ
Knife, Tonsil
KBR
Needle, Tonsil Suturing
KBS
Punch, Adenoid
KBT
Punch, Tonsil
KBW
Screw, Oral
KBX
Screw, Tonsil
KBY
Set, Filliform, Eustachian
KBZ
Snare, Tonsil
KCA
Tonsillectome
KCB
Tube, Tonsil Suction
KCC
Bistoury, Tracheal
KCD
Bougie, Esophageal, Ent
KCF
Dilator, Esophageal, Ent
KCG
Dilator, Tracheal
KCH
Hook, Tracheal
KCI
Trocar, Tracheal
KTE
Trocar, Ent
KTF
Punch, Ent
KTG
Knife, Ent
KTI
Bronchoscope Accessory
KTR
Tube, Aspirating, Bronchoscope, Rigid
LJW
Tracheotome
LMS
Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
LRC
Instrument, Ent Manual Surgical
LXR
Laser, Microsurgical Argon, For Use In Otology
LYA
Splint, Intranasal Septal
MMO
Tray, Surgical, Ent
MQW
Transilluminator, Fiber Optic
MXP
Bone Particle Collector
NLB
Trocar, Tracheal, Laryngeal, Sinus, Reprocessed
NLE
Forceps, Biopsy, Bronchoscope (Non-Rigid), Reprocessed
NLY
Microdebrider, Ent, High Speed, Single Use, Reprocessed
NLZ
Bur, Ent, Diamond Coated, Single Use, Reprocessed
OGR
Ear, Nose, And Throat Surgical Tray
OGU
Pierced Ear/Entry Cleaning Tray
PNZ
Eustachian Tube Balloon Dilation Device
QGK
Balloon, Nasal Airway
QJL
Splint, Intranasal Septal, Cber Led
QNW
Reprocessed Bronchoscope
QQH
Powered Insertion System For A Cochlear Implant Electrode Array
OLL
Septal Stapler/Absorbable Staples
SBS
Laryngeal Injection Set With Led Light
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—General Hospital and Personal Use Miscellaneous Devices
Subpart G—Miscellaneous Devices
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
EN
/
subpart-e—surgical-devices
/
ERL
/
K781418
View Source
XOMED TRANSSPHENOIDAL HANDPIECE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K781418
510(k) Type
Traditional
Applicant
XOMED, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/31/1978
Days to Decision
15 days