FDA.reportPublic FDA data

PRECISOR

Primary DI
10653405051909
Brand
PRECISOR
Company
Conmed Corporation
Model
000852
Catalog number
000852
Device description
PRECISOR Hot Disposable Hot Biopsy Forceps, 230cm, Oval Cup, Olympus
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGEFORCEPS, BIOPSY, ELECTRIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGEForceps, Biopsy, ElectricGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K905088000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905088000HOT BIOPSY FORCEPSEsco Precision, Inc.1991-03-19KGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653405051909PackageGS110In Commercial Distribution
20653405051906PrimaryGS10
00653405051902Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065340505190910653405051909
2065340505190620653405051906
00653405051902006534050519026534050519020653405051902

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
Length230Centimeter
Outer Diameter2.8Millimeter
Width2.3Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature-29 Degrees Celsius60 Degrees Celsius
Handling Environment Temperature-20 Degrees Fahrenheit140 Degrees Fahrenheit
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(800)237-0169CUSTOMER_SERVICE@CONMED.COM
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
10
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

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10845854084137AirSeal®iAS8-dVLiAS8-dVL2023-01-06
10845854013137QUICKLATCHQL4300QL43002020-12-10
10845854031841CONMEDT2531T25312020-12-10
10845854036204POWERPROPRO6185PRO61852023-09-01
20845854061807SnapEvacSNAPEVAC20SNAPEVAC202020-06-06
30653405011907EXCEL60-6050-00160-6050-0012016-09-24
30653405988346Argo KnotlessK55RTAPK55RTAP2023-01-13
30653405988360Argo KnotlessK475RTAPK475RTAP2023-01-13
10845854032619CROSSFTTFT-45MTFT-45M2021-01-19
10845854032633CROSSFTTFT-55MTFT-55M2021-01-19
10845854032657CROSSFTTFT-65MTFT-65M2021-01-19
10653405004646ELECTROLASE HYFRECATOR7-100-8BX7-100-8BX2016-09-24
10653405013785THERMOGARD7-3847-3842016-09-24
10845854650134THERMOGARD7-3827-3822022-09-21
20653405051906Precisor0008520008522016-09-24
20653405051920Precisor0008540008542016-09-24
30653405046800BiCap SuperconductorBP-10300ABP-10300A2016-09-24
30653405046992BiCap SuperconductorBP-7300ABP-7300A2016-09-24
30653405047005BiCap SuperconductorBP-5200ABP-5200A2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664913871NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913888NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913895NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913901NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913918NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913925NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913932NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913949NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913956NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913963NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913970NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913987NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
04953170466038Single Use Electrosurgical Hemostatic ForcepsOLYMPUS MEDICAL SYSTEMS CORP.KGE2026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsOLYMPUS MEDICAL SYSTEMS CORP.KGE2026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsOLYMPUS MEDICAL SYSTEMS CORP.KGE2026-04-01
08809327353293ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
08809327353316ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
08809327353323ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
08809327355518ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
08809327355808ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327353290ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327353313ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327353320ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327355515ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327355805ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
04953170466243DISPOSABLE HOT BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.KGE2025-11-19
04953170466250DISPOSABLE HOT BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.KGE2025-11-19
06934415022309ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19
06934415022316ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19
06934415022323ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19