FDA.reportPublic FDA data

PhotonBlade®

Primary DI
00816728020523
Brand
PhotonBlade®
Company
INVUITY, INC.
Model
PhotonBlade Breast Kit
Catalog number
PBPG1
Device description
The PhotonBlade Breast Kit consists of (1) PhotonBlade packaged with a (1) PhotonGuide, Wide / Angled illuminator for the convenience of the user. The PhotonBlade is an RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during surgical procedures. It is intended to be used with a variety of standard commercially available electrosurgical units. The PhotonGuide is intended to provide surgical site illumination from a high intensity light source.
Published
2018-02-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162053000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162053000PhotonBladeInvuity, Inc.2016-09-15GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816728020523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816728020523008167280205238167280205230816728020523

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical electrode, monopolar, single-useAn invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8667117768customerservice@invuity.com

Regulatory Flags#

DUNS number
175697908
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816728020165Synthes Fiber Optic CableSingle115001, 03.809.7332016-09-22
00816728020172Synthes Fiber Optic CableBifurcated115002, 03.809.7342016-09-22
00816728020189Invuity® Fiber Optic CableSingle1100002016-09-22
00816728020219Invuity® Fiber Optic CableBifurcated1100012016-09-22
00816728020233Eikon Sterilization TrayNarrowST1B2016-09-22
00816728020264Invuity® Sterilization TraySmall1102002016-09-22
00816728020271Invuity® Fiber Optic Sterilization TrayLarge1102102016-09-22
00816728020288Invuity® Steam Sterilization Tray1.5 x 6 x 10 in110702016-09-22
00816728020295Invuity® Steam Sterilization Tray1.5 x 10 x 15 in111852016-09-22
00816728020301Breiten Sterilization TrayNarrow109642016-09-22
00816728020318Breiten Sterilization TrayStandard109652016-09-22
00816728020455PhotonSaber YFin TipES2Y2016-09-22
00816728020639PhotonBlade™PB1PB12019-06-03
00816728020653PhotonGuideWide / Angled1025212019-06-03
00816728021575Eikon LT Adapt Smoke Evacuation90mm RetractorA90SE2019-08-09
00816728021582Eikon LT Adapt Smoke Evacuation90mm, Teeth RetractorA90TSE2019-08-09
00816728021124Eikon LT Adapt Smoke Evacuation90mm, Wide, RetractorA90WSE2019-10-07
00816728021131Eikon LT Adapt Smoke Evacuation90mm, Wide, Teeth RetractorA90WTSE2019-10-07
00816728021599Eikon LT Adapt Smoke Evacuation135mm RetractorA135SE2019-08-09
00816728021605Eikon LT Adapt Smoke Evacuation135mm, Teeth RetractorA135TSE2019-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846338006044Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006051Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006068Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006082Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006099Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006105Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006112Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006129Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006136Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006143Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006150Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006167Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006174Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006181Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006198Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006204Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006211Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006228Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006235Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006242Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006259Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006266Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006273Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006310Empire MicroIncision ElectrodeELLIQUENCE, LLCGEI2026-06-02
00846338006341Triple Footswitch & CableELLIQUENCE, LLCGEI2026-06-02
00846338007133Trigger-Flex Quad Pro Bipolar SystemELLIQUENCE, LLCGEI2026-06-02
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCGEI2026-06-02
00846338004712Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01
00846338004729Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01
00846338004736Monopolar ElectrodeELLIQUENCE, LLCGEI2026-06-01