General & Plastic Surgery Microwave Medical Products
Definition: Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www. Gpo. Gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007. Pdf).
Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]
Radiation Type | Microwave EMF |
Radition Safety | Abbreviated |
Annual Reports | No |
5648 | Electrosurgical, Cutting & Coagulation & Accessories | Electrosurgical Cutting And Coagulation Device And Accessories. |
5648 | Electrosurgical, Cutting & Coagulation & Accessories | Electrosurgical Cutting And Coagulation Device And Accessories. |
Electrosurgical, Cutting & Coagulation & Accessories [29857] | 21 CFR §878.4400 🔎 |
Electrosurgical, Cutting & Coagulation & Accessories [29857] | 21 CFR §878.4400 🔎 |
Electrosurgical, Cutting & Coagulation & Accessories [29857] | 21 CFR §878.4400 🔎 |
Electrosurgical, Cutting & Coagulation & Accessories [29857] | 21 CFR §878.4400 🔎 |
Electrosurgical, Cutting & Coagulation & Accessories [29857] | 21 CFR §878.4400 🔎 |
Electrosurgical, Cutting & Coagulation & Accessories [29857] | 21 CFR §878.4400 🔎 |
Electrosurgical, Cutting & Coagulation & Accessories [29857] | 21 CFR §878.4400 🔎 |
Electrosurgical, Cutting & Coagulation & Accessories [29857] | 21 CFR §878.4400 🔎 |
Electrosurgical, Cutting & Coagulation & Accessories [29857] | 21 CFR §878.4400 🔎 |
Electrosurgical, Cutting & Coagulation & Accessories [29857] | 21 CFR §878.4400 🔎 |
Electrosurgical, Cutting & Coagulation & Accessories [29857] | 21 CFR §878.4400 🔎 |
Electrosurgical, Cutting & Coagulation & Accessories [29857] | 21 CFR §878.4400 🔎 |
K223292 | TempSure System | Cynosure LLC |
K223110 | TruSculpt ID | Cutera Inc. |
K222793 | WavelinQ™ Generator | C.R. Bard, Inc. |
K222429 | Ellusa Reusable Bipolar Cable | Ellusa, LLC |
K222425 | Ellusa Reusable Neutral Plates | Ellusa, LLC |
K222284 | Voyant Maryland Fusion Device With Single-Step Activation (EB212, EB213, EB214) | Applied Medical Resources Corporation |
K222075 | CellFX System | Pulse Biosciences, Inc. |
K222032 | NEUROMARK System | Neurent Medical |
K221989 | The Oligio | WON TECH Co., Ltd. |
K221945 | Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm X 160 Cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 Mm X 320 Cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 Mm X 230 Cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 Mm X 320 Cm, Beamer AVEO FIL | Conmed Corporation |
K221907 | RhinAer® Stylus (FG1393) | Aerin Medical Inc. |
K221830 | Apyx One Console | Apyx Medical Corporation |
K221815 | Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De); Electrosurgical Pencil (OBS-Dt, OBS-Dd, OBS-Ds, OBS-Dl, OBS-Da) | Baisheng Medical Co., Ltd. |
K221407 | TruSculpt ID | Cutera Inc. |
K221277 | Mygen M-3004 RF Generator M-3004 | RF Medical Co., Ltd |
00501986000121 | Electrosurgical, Cutting & Coagulation & Accessories |
10381780177340 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
10381780176985 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
30381780169356 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
30381780169349 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
30381780169332 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
10381780169321 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
30381780169318 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
30381780169301 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
10381780169291 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
30381780169288 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
30381780169271 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
10381780165842 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
10381780165835 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
10381780024989 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
LIGASURE | COVIDIEN MFG DC BOULDER | 2020-03-31 |
LIGASURE | COVIDIEN MFG DC BOULDER | 2020-03-31 |
LIGASURE IMPACT | COVIDIEN MFG DC BOULDER | 2020-03-31 |
LIGASURE | COVIDIEN MFG DC BOULDER | 2020-03-31 |
LIGASURE | COVIDIEN MFG DC BOULDER | 2020-03-31 |
ENSEAL G2 CURVED JAW 35CM | ETHICON ENDO-SURGERY, LLC. | 2020-03-31 |
ENSEAL 5MM ROUND TIP 35CM | ETHICON ENDO-SURGERY, LLC. | 2020-03-31 |
ENSEAL G2 CURVED JAW 35CM | ETHICON ENDO-SURGERY, LLC. | 2020-03-31 |
EB210, VOYANT 5MM FUSION 37CM, 6/BX | APPLIED MEDICAL RESOURCES | 2020-03-31 |
EB210, VOYANT 5MM FUSION 37CM, 6/BX | APPLIED MEDICAL RESOURCES | 2020-03-31 |
VALLEYLAB | COVIDIEN MFG DC BOULDER | 2020-03-31 |
VAPR3 GENERATOR *EA | DEPUY MITEK LLC US | 2020-03-31 |
EB210, VOYANT 5MM FUSION 37CM, 6/BX | APPLIED MEDICAL RESOURCES | 2020-03-31 |
THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-03-31 |
PLASMABLADE 3.0S | MEDTRONIC ADVANCED ENERGY, LLC | 2020-03-31 |
VAPR VUE GENERATOR | DEPUY MITEK LLC US | 2020-03-31 |
LIGASURE | COVIDIEN MFG DC BOULDER | 2020-03-31 |
RF 2 PROBES, MICRO-CLAW | STRYKER ENDOSCOPY-SAN JOSE | 2020-03-31 |
CAIMAN MARYLAND ARTICULATING D5/360MM | AESCULAP AG | 2020-03-31 |
LIGASURE | COVIDIEN LLC | 2020-03-31 |
LIGASURE | COVIDIEN LLC | 2020-03-31 |
ENSEAL | ETHICON ENDO-SURGERY, INC | 2020-03-31 |
LIGASURE | COVIDIEN MFG DC BOULDER | 2020-03-31 |
LIGASURE | COVIDIEN MFG DC BOULDER | 2020-03-31 |
LIGASURE | COVIDIEN MFG DC BOULDER | 2020-03-31 |
ERBE APC 2 | ERBE ELEKTROMEDIZIN GMBH | 2020-03-31 |
LIGASURE | COVIDIEN MFG DC BOULDER | 2020-03-31 |
EDGE | COVIDIEN MFG DC BOULDER | 2020-03-31 |
EDGE | COVIDIEN MFG DC BOULDER | 2020-03-31 |
SURGISTAT | COVIDIEN MFG DC BOULDER | 2020-03-31 |
EMPRINT | COVIDIEN LP - SUPERDIMENSION INC | 2020-03-31 |
VALLEYLAB FT10 | COVIDIEN MFG DC BOULDER | 2020-03-31 |
LIGASURE | COVIDIEN MFG DC BOULDER | 2020-03-31 |
VALLEYLAB | COVIDIEN MFG DC BOULDER | 2020-03-30 |
VAPR VUE WIRELESS FOOTSWITCH | DEPUY MITEK LLC US | 2020-03-30 |
LIGASURE | COVIDIEN MEDICAL PRODUCTS | 2020-03-30 |
FORCE FX | COVIDIEN MFG DC BOULDER | 2020-03-30 |
LIGASURE | COVIDIEN MFG DC BOULDER | 2020-03-30 |
LIGASURE | COVIDIEN MFG DC BOULDER | 2020-03-30 |
ATR.UNI.FIX FORCEPS W/GROOVES D:5/310MM | AESCULAP AG | 2020-03-30 |
LIGASURE IMPACT | COVIDIEN MFG DC BOULDER | 2020-03-30 |
ATR.UNI.FIX FORCEPS W/GROOVES D:5/310MM | AESCULAP AG | 2020-03-30 |
MONOPOLAR HANDLE WITH RATCHET | AESCULAP AG | 2020-03-30 |
SMOKE EVAC. PENCIL, PB, COATED | LINA MEDICAL APS | 2020-03-30 |
LIGASURE | COVIDIEN LP | 2020-03-30 |
ULTRACLEAN 6IN. BLADE EXTENDED INSULATION | CONSOLIDATED MEDICAL EQUIPMENT | 2020-03-30 |
LIGASURE | COVIDIEN LP | 2020-03-30 |
THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S | OLYMPUS MEDICAL SYSTEMS CORP. | 2020-03-30 |
AMBIENT SUPER MULTIVAC 50 IFS | ARTHROCARE CORP. | 2020-03-29 |
SUPER TURBOVAC 90 ICW | ARTHROCARE CORP. | 2020-03-28 |