FDA.reportPublic FDA data

Olympus

Primary DI
14953170035965
Brand
Olympus
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
SD-7P-1
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955650000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955650000OLYMPUS SD SERIES SNARESOlympus America, Inc.1996-03-29FDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14953170035965PackageGS11In Commercial Distribution
04953170035968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1495317003596514953170035965
04953170035968049531700359684953170035968

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, reusableAn 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 is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
711789789
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170158759DISPOSABLE HOT BIOPSY FORCEPSFD-210U2016-09-21
04953170158766DISPOSABLE HOT BIOPSY FORCEPSFD-230U2016-09-21
04953170354236DISPOSABLE HOT BIOPSY FORCEPSFD-210UN53565302016-09-21
04953170354243DISPOSABLE HOT BIOPSY FORCEPSFD-230UN53566302016-09-21
04953170214288RECORDER UNIT HARNESSMAJ-1475N24838302023-06-21
04953170331718Light guideOCS5-LG2016-09-21
04953170333316RECORDER HOLDERMAJ-2033N44720302016-09-21
04953170467592DISPOSABLE BIOPSY FORCEPSFB-211DN54318422026-04-09
04953170467608DISPOSABLE BIOPSY FORCEPSFB-221DN54319422026-04-09
04953170467615DISPOSABLE BIOPSY FORCEPSFB-231DN54320422026-04-09
04953170467622DISPOSABLE BIOPSY FORCEPSFB-241DN54321422026-04-09
04953170466038Single Use Electrosurgical Hemostatic ForcepsFD-410LRN10861412026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsFD-411URN30463402026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsFD-412LRN53686402026-04-01
04953170035647ELECTROSURGICAL SNARESD-5L-12016-09-21
04953170035708ELECTROSURGICAL SNARESD-5U-12016-09-21
04953170035838ELECTROSURGICAL SNARESD-6U-12016-09-21
04953170035951ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170035968ELECTROSURGICAL SNARESD-7P-12016-09-21
04953170036033ELECTROSURGICAL SNARESD-8P-12016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08904148101587ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
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08904148101617ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101624ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101822ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101839ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101846ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101853ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
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08904148101877ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148101891ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
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08904148102164ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
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08904148105868ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148105875ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148105882ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148106322ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
08904148106346ACEACE MEDICAL DEVICES PRIVATE LIMITEDFAS2025-04-28
10801334000707Greenwald Surgical Company, Inc.GRACE MANUFACTURING, INC.FAS2017-05-03
08714729875604Signature Series PROSURG INCFAS2016-09-30
07613327055313NASTRYKER CORPORATIONFAS2016-09-23
07613327055399NASTRYKER CORPORATIONFAS2016-09-23
07613327055405NASTRYKER CORPORATIONFAS2016-09-23