FDA.reportPublic FDA data

Signature Series

Primary DI
08714729753544
Brand
Signature Series
Company
PROSURG INC
Model
M0068805410
Device description
Electrosurgical Devices, Incision Blade
Published
2016-09-23
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

Product Codes#

Code, Name table
CodeName
FASElectrode, Electrosurgical, Active, Urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962593000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962593000ELECTROSURGICAL PROBES & DEVICESXimed/Prosure/Injectx1996-11-12GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729258391PackageGS110In Commercial Distribution
08714729753544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729258391087147292583918714729258391
08714729753544087147297535448714729753544

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical systemAn assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for inert gas-enhanced electrosurgery.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge24French

Contacts#

Phone, Email table
PhoneEmail
408 945 4044Prosurg_qa@sbcglobal.net

Regulatory Flags#

DUNS number
188684609
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851545007715ProsurgNAR40NAR402020-05-12
00851545007722ProsurgNAN18NAN182020-05-12
00851545007814ProsurgNAN23NAN232020-05-12
10851545007712ProsurgNAR40NAR402020-05-12
10851545007729ProsurgNAN18NAN182020-05-12
10851545007811ProsurgNAN23NAN232020-05-12
08714729516750Signature Series M00688025702016-09-23
08714729520375Signature Series M00688020702016-09-23
08714729520382Signature Series M00688021502016-09-23
08714729520405Signature Series M00688021702016-09-23
08714729520412Signature Series M00688022502016-09-23
08714729520429Signature Series M00688022602016-09-23
08714729520436Signature Series M00688022702016-09-23
08714729520443Signature Series M00688023502016-09-23
08714729520450Signature Series M00688023602016-09-23
08714729520467Signature Series M00688023702016-09-23
08714729520474Signature Series M00688024502016-09-23
08714729520481Signature Series M00688024602016-09-23
08714729520498Signature seriesM00688024702016-09-23
08714729520504Signature Series M00688025502016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810143893137Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893144Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893151Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893168Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893175Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893182Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893199Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893205Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893212Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893229Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893236Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893243Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893250Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893267Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893274Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893281Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893298Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893304Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893311Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-21
00810143893007Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-20
00810143893014Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-20
00810143893021Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-20
00810143893038Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-20
00810143893045Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-20
00810143893052Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-20
00810143893069Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-20
00810143893076Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-20
00810143893083Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-20
00810143893090Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-20
00810143893106Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAS2026-07-20