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
00190776429140MillenniumAvalign Technologies, Inc.GEI2026-09-04
00840113233281BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233304BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233328BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233342BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233366BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233380BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233403BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233427BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233441BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233465BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233489BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233502BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233526BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237326BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237340BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237593BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237623BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237661BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237692BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26