FDA.reportPublic FDA data

Modulap

Primary DI
00817428020738
Brand
Modulap
Company
ATC TECHNOLOGIES, INC.
Model
4155
Device description
4155 Modulap Mono Polar Electrode Probe, 5mm, Loop , Disposable
Published
2016-09-24
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
KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNFCoagulator-Cutter, Endoscopic, Unipolar (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121343000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121343000MODULAP LOOPAtc Technologies, Inc.2013-06-14KNF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817428020738PackageGS15In Commercial Distribution
00817428020721PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817428020738008174280207388174280207380817428020738
00817428020721008174280207218174280207210817428020721

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, single-useA sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023131605
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
00817428021537Modulap347934792026-04-14
00817428021544Modulap31562026-04-14
00817428021551Modulap45832026-03-20
10817428021558Modulap45832026-03-20
00817428021490Modulap31302025-07-21
00817428021506Modulap40422025-07-21
00817428021520Modulap312831282025-07-21
10817428021503Modulap40422025-07-21
00817428021513Modulap45992025-05-07
10817428021510Modulap45992025-05-07
00817428021469Modulap41402025-03-26
10817428021022Modulap41412025-03-26
10817428021046Modulap41432025-03-26
10817428021053Modulap41442025-03-26
00817428021018Modulap414041402019-08-15
00817428021025Modulap414141412019-08-15
00817428021032Modulap414241422019-08-15
00817428021049Modulap414341432019-08-15
00817428021056Modulap414441442019-08-15
10817428021480MODULAP45812024-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708265016280LiNA Gold Loop™LiNA Medical AGKNF2026-04-02
05708265016327LiNA Gold Loop™LiNA Medical AGKNF2026-04-02
05708265016365LiNA Gold Loop™LiNA Medical AGKNF2026-04-02
10817929020364Sonata® Dispersive ElectrodeGynesonics, Inc.KNF2021-07-07
30817929020177Sonata® RFA Handpiece Cable, ReusableGynesonics, Inc.KNF2021-07-07
14042761086254OlympusOLYMPUS Winter & Ibe GmbHKNF2020-07-31
14042761086278OlympusOLYMPUS Winter & Ibe GmbHKNF2020-07-31
00810116021666Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-19
00810116021673Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-19
00810116021680Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-19
00810116021642Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-18
00810116021659Dornier MedTechDORNIER MEDTECH AMERICA, INC.KNF2020-06-18
10817929020241Sonata® Intrauterine Ultrasound ProbeGynesonics, Inc.KNF2019-05-10
10817929020142Sonata® IUUS Probe Soaking CylinderGynesonics, Inc.KNF2019-05-10
10817929020180Sonata® System Cart Gynesonics, Inc.KNF2019-05-10
10817929020197Sonata® SMART TabletGynesonics, Inc.KNF2019-05-10
10817929020203Sonata® System Radiofrequency GeneratorGynesonics, Inc.KNF2019-05-10
10817929020326Sonata® Sonography-Guided Transcervical Fibroid Ablation System Gynesonics, Inc.KNF2019-05-10
30817929020092Sonata® Intrauterine Ultrasound ProbeGynesonics, Inc.KNF2019-05-10
10381780490128Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKNF2019-03-06
10381780490135Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONKNF2018-09-14
04048551102503n.a.Karl Storz GmbH & Co. KGKNF2018-07-21
04048551102527n.a.Karl Storz GmbH & Co. KGKNF2018-07-21
04048551094631BETTOCCHIKarl Storz GmbH & Co. KGKNF2017-10-20
04048551364864n.a.Karl Storz GmbH & Co. KGKNF2017-05-19
04048551347645n.a.Karl Storz GmbH & Co. KGKNF2016-12-22
10653405035060CONMEDConmed CorporationKNF2016-09-24
10653405035091CONMEDConmed CorporationKNF2016-09-24
00817428020721ModulapATC TECHNOLOGIES, INC.KNF2016-09-24
04046963682262AESCULAPAesculap AGKNF2016-09-24