FDA.reportPublic FDA data

Single Use Electrosurgical Snare SD-400

Primary DI
14953170396691
Brand
Single Use Electrosurgical Snare SD-400
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
SD-400-10
Published
2017-12-13
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
FGXSNARE, NON-ELECTRICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGXSnare, Non-ElectricalGastroenterology, Urology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172734000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172734000Single Use Electrosurgical Snare SD-400Olympus Medical Systems Corp.2017-12-07FDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170396691PackageGS110In Commercial Distribution
04953170396694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317039669114953170396691
04953170396694049531703966944953170396694

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170373763ENDOCAPSULE SOFTWARE 10MAJ-2188N54003402016-09-21
04953170373800ENDOCAPSULE SOFTWARE 10 LIGHTMAJ-2189N54004402016-09-21
04953170373848ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGEMAJ-2190N54005402016-09-21
04953170360817ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENTMAJ-2038N53688402023-06-21
04953170360824ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENTMAJ-2039N53689402023-06-21
04953170410178EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPEOLYMPUS GF-UE190N60031402025-11-19
04953170411939Single Use Biopsy Forceps FB-456DFB-456DN60083302020-09-29
04953170424724Infrared imaging unitMAJ-2304N57695452021-05-31
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170054358BrushMH-36241168002016-09-21
04953170058783BALLOON3MAJ-2332017-10-12
04953170058882BALLOON3MAJ-2492017-10-12
04953170142628SonoSurg TransducerSonoSurg-T2H-C2017-10-06
04953170208485Cleaning brushMAJ-1534N23010002016-09-21
04953170234859SonoSurg Straight Scissors,Pistol Grip,5mm x 34cmT37712017-10-06
04953170234880SonoSurg Curved Scissors,Pistol Grip,5mm x 34cmT37752017-10-06
04953170234941SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 34cmT39002017-10-06
04953170235030SonoSurg Curved Scissors,HF,Inline Grip,5mm x 34cmT39152017-10-06
04953170235122SonoSurg Straight Scissors,HF,Pistol Grip,5mm x 19cmT39302017-10-06
04953170235153SonoSurg Curved Scissors,HF,Pistol Grip,5mm x 19cmT39352017-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664902073NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902097NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902110NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902127NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902134NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902141NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902158NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902172NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902196NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902202NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902219NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902226NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902233NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902240NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902257NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902264NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902271NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902288NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902295NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664902301NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664908921NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664908938NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664908945NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664908952NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664908983NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664908990NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664909003NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664909027NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664909034NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22
06959664909041NAHangzhou AGS MedTech Co., Ltd.FGX2026-07-22