FDA.reportPublic FDA data

CONMED

Primary DI
30653405034449
Brand
CONMED
Company
Conmed Corporation
Model
60-5163-004
Catalog number
60-5163-004
Device description
Laparoscopic Electrode with 4 mm Pin and Disposable Cord, L-HOOK 5 mm x 32 cm
Published
2016-09-24
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
HFGCOAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFGCoagulator, Laparoscopic, Unipolar (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K904240000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904240000SINGLE USE LAPARSCOPIC ELECTRODEAspen Labs1991-02-19HFG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20653405034442PackageGS15In Commercial Distribution
30653405034449PrimaryGS10
00653405034448Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2065340503444220653405034442
3065340503444930653405034449
00653405034448006534050344486534050344480653405034448

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length32Centimeter
Outer Diameter5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
5
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20845854042004Y-KNOTYH01YH012015-10-24
20845854042028Y-KNOTYH02YH022015-10-24
10845854087534Infinity™QTSLQTSL2026-06-10
10845854087541Infinity™QTSRQTSR2026-06-10
10845854087558Infinity™RDBHRDBH2026-06-10
20653405990328Infinity™QTCRQTCR2026-06-10
20653405990366Infinity™ADB-0808ADB-08082026-06-10
20653405990373Infinity™ADB-0609ADB-06092026-06-10
20653405990380Infinity™ADB-0809ADB-08092026-06-10
20653405990397Infinity™ADB-0610ADB-06102026-06-10
20653405990403Infinity™ADB-0810ADB-08102026-06-10
20653405990410Infinity™ADB-0611ADB-06112026-06-10
20653405990427Infinity™DB-0808DB-08082026-06-10
20653405990434Infinity™DB-0609DB-06092026-06-10
20653405990441Infinity™DB-0809DB-08092026-06-10
20653405990458Infinity™DB-0610DB-06102026-06-10
20653405990465Infinity™DB-0810DB-08102026-06-10
20653405990472Infinity™DB-0611DB-06112026-06-10
10653405002765ABC® Bend-A-Beam®1340091340092016-09-24
10845854015506CONMEDC2630C26302015-12-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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15420045515291Acessa ProVu SystemHologic, Inc.HFG2024-09-13
15420045515246Acessa ProVu SystemHologic, Inc.HFG2023-05-16
15420045515253Acessa ProVu SystemHologic, Inc.HFG2023-05-16
15420045515307Acessa ProVu SystemHologic, Inc.HFG2023-05-16
15420045515314Acessa ProVu SystemHologic, Inc.HFG2023-05-16
15420045515284Acessa ProVu SystemHologic, Inc.HFG2022-11-08
00854763006256Acessa ProVu Dual Foot Pedal ACESSA HEALTH INC.HFG2020-12-07
14042761086278OlympusOLYMPUS Winter & Ibe GmbHHFG2020-07-31
00854763006102Acessa PadsACESSA HEALTH INC.HFG2018-10-11
00854763006119Acessa Pad CableACESSA HEALTH INC.HFG2018-10-11
00854763006126Acessa Table Top Field GeneratorACESSA HEALTH INC.HFG2018-10-11
00854763006140Acessa ProVu HandpieceACESSA HEALTH INC.HFG2018-10-11
00854763006157Acessa ProVu Handpiece CableACESSA HEALTH INC.HFG2018-10-11
00854763006188Acessa ProVu Transducer with sensorACESSA HEALTH INC.HFG2018-10-11
00854763006195Acessa ProVu Planar Field Generator (PFG)ACESSA HEALTH INC.HFG2018-10-11
00854763006232Acessa ProVu SystemACESSA HEALTH INC.HFG2018-10-11
00854763006249Acessa ProVu PFG Table ClampACESSA HEALTH INC.HFG2018-10-11
30653405009652CONMEDConmed CorporationHFG2016-09-24
30653405009669CONMEDConmed CorporationHFG2016-09-24
30653405009676CONMEDConmed CorporationHFG2016-09-24
30653405009683CONMEDConmed CorporationHFG2016-09-24
30653405009744CONMEDConmed CorporationHFG2016-09-24
30653405009768CONMEDConmed CorporationHFG2016-09-24
30653405009775CONMEDConmed CorporationHFG2016-09-24
30653405009782CONMEDConmed CorporationHFG2016-09-24
30653405009799CONMEDConmed CorporationHFG2016-09-24
30653405034784NAConmed CorporationHFG2016-09-24
30653405034807CONMEDConmed CorporationHFG2016-09-24