Anesthesiology
Review Panel
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- ChemistryReview Panel
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- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
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- HematologyReview Panel
- ImmunologyReview Panel
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- NeurologyReview Panel
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- OphthalmicReview Panel
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- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- MVFSystem, Laser, Photodynamic Therapy3Product Code
- MVGSystem, Laser, Fiber Optic, Photodynamic Therapy3Product Code
- MWZExpander, Breast, ExternalUProduct Code
- MYHSystem, Non-Coherent Light, Photodynamic Therapy3Product Code
- NBESealant, Polymerizing3Product Code
- PBDComposite Cultured SkinFProduct Code
- QPEPhototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions2Product Code
- MTJWax, BoneUProduct Code
- DTHSuture, Cardiovascular3Product Code
- DZGSuture, Dental3Product Code
- EFQGauze/Sponge, InternalUProduct Code
- EYFProtector, Wound, PlasticUProduct Code
- FRODressing, Wound, DrugUProduct Code
- GELGauze/Sponge, Internal, With Drug/Biologic, Animal Source MaterialUProduct Code
- GERGauze, External (With Drug/Biologic/Animal Source Material)UProduct Code
- HMNSuture, Nonabsorable, Ophthalmic3Product Code
- HMOSuture, Absorbable, Ophthalmic3Product Code
- KGMSilicone, Liquid, Injectable3Product Code
- KGNDressing, Wound, CollagenUProduct Code
- LCJExpander, Skin, InflatableUProduct Code
- LFLInstrument, Ultrasonic SurgicalUProduct Code
- LMHImplant, Dermal, For Aesthetic Use3Product Code
- LMIImplant, Collagen For Non-Aesthetic Use3Product Code
- LRQTracheostomy And Nasal Suctioning Kit1Product Code
- LRRFirst Aid Kit With DrugNProduct Code
- LXULaser For Wound Healing3Product Code
- MAWMarker, Suture IdentificationUProduct Code
- MDDDevice, Dermal Replacement3Product Code
- MGPDressing, Wound And Burn, OcclusiveUProduct Code
- MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUProduct Code
- MGRDressing, Wound And Burn, Interactive3Product Code
- MQZProsthesis, NailUProduct Code
- MRDSizer, Mammary, Breast Implant VolumeUProduct Code
- MSADressing, Wound And Burn, Occlusive, HeatedUProduct Code
- NLQScalpel, Ultrasonic, ReprocessedUProduct Code
- NQKMaggots, MedicalUProduct Code
- NRNLeeches, MedicinalUProduct Code
- NSSElectronic Media, NauseaNProduct Code
- NZFStatic Electricity-Emitting Device, Cosmetic UseNProduct Code
- OCECultured Epithelial AutograftFProduct Code
- ODSWound Covering (Composite Cultured Skin)FProduct Code
- OEEDiagnostic Low Electric Field3Product Code
- OJIBurn Kit With DrugNProduct Code
- ONVElectrical Impedance Spectrometer3Product Code
- OYDOptical Diagnostic Device For Melanoma Detection3Product Code
- PFCCultured Human Cell Skin Dressing3Product Code
- PHUIntra-Abdominal Pressure Monitoring DeviceUProduct Code
- PKYImplant, Dermal, For Aesthetic Use In The Hands3Product Code
- PUVLymph Node Location System During Sentinel Biopsy Procedure3Product Code
- PZCAblation System, High Intensity Focus Ultrasound (Hifu), Soft TissueNProduct Code
- QOJApparatus, Suction, Operating-Room, Wall Vacuum Powered (Export Only)NProduct Code
- QQFSkin Microneedling Manual/Automated Device (Export Only)NProduct Code
- QVSBreast Implant Suction Retrieval Device2Product Code
- QVXSkin Patch For Treatment Of Hyperhidrosis2Product Code
- PLJTissue Adhesive Internal Use3Product Code
- QSXHemostatic Wound Dressing With Thrombin Or Other BiologicsUProduct Code
- QSYHemostatic Wound Dressing Without Thrombin Or Other BiologicsUProduct Code
- QSZAbsorbable Synthetic Wound DressingUProduct Code
- QGMFocused Ultrasound System For Non-Thermal, Mechanical Tissue Ablation2Product Code
- QZSSoftware-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer2Product Code
- SABTable Mounted Miniaturized Electromechanical Surgical System2Product Code
- SAQElectromechanical System For Open Microsurgery2Product Code
- SAWFluorescence Imaging For Breast Cancer Detection3Product Code
- QMLAnal Fistula Closure Device2Product Code
- SAHMagnetic Compression Anastomosis System2Product Code
- QYKSemi-Automated Autologous Skin Graft Harvesting And Application Device2Product Code
- SCVModular Electromechanical Surgical System2Product Code
- SDDElectromechanical Surgical System Wherein The Surgeon Annd The User Interface Can Be In The Sterile Field2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Semi-Automated Autologous Skin Graft Harvesting And Application Device
- Page Type
- Product Code
- Definition
- A semi- automated autologous skin graft harvesting and application device is a handheld electromechanical surgical instrument that extracts autologous skin graft tissue from a healthy donor skin site and deposits it to a recipient site. The device extraction and deposition functions are automated and are activated by the user. The device is not intended for treatment of third degree burns.
- Physical State
- The device consists of (1) a handheld electronically controlled unit with built in software and user interface and (2) a tissue collection/deposition accessory that engages with the handheld unit and is used to acquire, transfer, and deposit skin tissue. The device may also consist of accessory components, e.g., a protective sleeve.
- Technical Method
- The essential components of the device are (1) a handheld unit that allows the user to control the device’s function via software and a user interface on the device, (2) a tissue collection/deposition accessory, e.g., a needle cartridge containing an array of coring needles and plungers that is used to collect, transfer, and deposit the hull thickness skin grafts from the donor site to the recipient site, respectively. The device may also include optional accessories, e.g., a protective sleeve that is used to lessen the potential for soilage of the handheld unit during use. The user places the collection/deposition accessory onto the donor site and, upon activating the collection f
- Target Area
- Skin
- Regulation Medical Specialty
- General and Plastic Surgery
- Review Panel
- General and Plastic Surgery
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 878.4795
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
Product code QYK is linked to regulation 21CFR878.4795, which does not seem to exist yet. It may be pending at the moment.