FDA.reportPublic FDA data

Signature Series

Primary DI
08714729520658
Brand
Signature Series
Company
PROSURG INC
Model
M0068805510
Device description
Electrosurgical Devices, Incision Blade
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
08714729520658PackageGS110In Commercial Distribution
08714729875604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729520658087147295206588714729520658
08714729875604087147298756048714729875604

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
188684609
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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