FDA.reportPublic FDA data

Single Use Electrosurgical Snare SD-400

Primary DI
14953170408240
Brand
Single Use Electrosurgical Snare SD-400
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
SD-400U-10
Published
2020-12-11
Public version status
New
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
14953170408240PackageGS110In Commercial Distribution
54953170408248PackageGS110In Commercial Distribution
04953170408243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317040824014953170408240
5495317040824854953170408248
04953170408243049531704082434953170408243

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
04953170468308Single Use BML Handle VMAJ-2502N61545312026-10-19
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170386138VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IR2021-02-07
04953170379611HD 3CMOS CAMERA HEADOLYMPUS CH-S200-XZ-EB2019-09-12
04953170386022VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS OTV-S2002019-09-12
04953170393204HD 3CMOS AUTOCLAVABLE CAMERA HEADOLYMPUS CH-S200-XZ-EA2019-09-12
04953170474958THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54233412026-10-05
04953170474965THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54234412026-10-05
04953170474972THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54236412026-10-05
04953170474989THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54237412026-10-05
04953170474996THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54239412026-10-05
04953170475009THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54240412026-10-05
04953170025693P CORDMAJ-348125002016-09-21
04953170048548A CORDMH-9692016-09-21
04953170062872A CORDMAJ-8602016-09-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936534328911Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328928Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328935Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328942Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328959Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328966Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328973Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328980Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534328997Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329000Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329017Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329024Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329031Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329048Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329055Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329062Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329079Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329086Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329093Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329109Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329116Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329123Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329130Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329147Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329154Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329161Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329178Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329185Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329192Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29
06936534329208Polypectomy Snare (NON-ELECTRICAL)Zhejiang Chuangxiang Medical Technology Co., LTD.FGX2026-09-29