FDA.reportPublic FDA data

PERCUVANCE

Primary DI
34026704640141
Brand
PERCUVANCE
Company
TELEFLEX INCORPORATED
Model
IPN029175
Catalog number
PCVHK5
Device description
5 MILLIMETER HOOK CAUTERY TIP
Published
2018-10-22
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

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
K181852000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181852000Percuvance Percutaneous Surgical SystemTeleflexmedical, Inc.2018-10-12GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34026704640141PackageGS16In Commercial Distribution
44026704640148PackageGS16In Commercial Distribution
14026704582829PreviousGS10
14026704640147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3402670464014134026704640141
4402670464014844026704640148
1402670458282914026704582829
1402670464014714026704640147

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece and may include a lumen for suction/irrigation; it requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2.6Inch
Width0.22Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-29 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature16 Degrees Celsius37 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
10801902213188ARROWIPN927188DLX-200-CURV2026-07-23
10841156108908TRAPLINERIPN91750955672026-07-23
10841156111311LANGSTONIPN93013555402026-07-23
14026704944450RUSCH2205000602205000602026-07-23
14026704945402RUSCH2204001402204001402026-07-23
14026704945419RUSCH2204001602204001602026-07-23
14026704945426RUSCH2205000802205000802026-07-23
14026704945617RUSCH2204000802204000802026-07-23
14026704945624RUSCH2204001002204001002026-07-23
14026704945846RUSCH2214000602214000602026-07-23
20801902193548ARROWIPN920133CS-15362-SPM2026-07-23
20801902193593ARROWIPN920138CS-15192-VF2026-07-23
14026704927453GIBECKIPN929805133122025-07-31
10801902226485ARROWIPNB00690ASK-21242-CWH12026-07-22
14026704624697RUSCHIPN04946312241102026-07-22
14026704911810PLEUR-EVACIPN927045S-1150-08LF2026-07-22
30801902193538ARROWIPN920132CS-15322-SPM2026-07-22
10841495149471QUIKCLOT1881882026-07-17
14026704645333WECKIPN9142504200232026-07-21
14026704714510LMA ATOMIZATIONIPN916119MAD300B2026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506092930ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506092947ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506093234ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
04250418748346Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
04250418753722Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
08800020100481POTENZA TipJeisys Medical Inc.GEI2026-07-21
08800020101754POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101761POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101778POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020110541INTRAcel PremiumJeisys Medical Inc.GEI2026-07-21
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16