FDA.reportPublic FDA data

Symmetry Surgical®

Primary DI
00887482087053
Brand
Symmetry Surgical®
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
98-1240L
Catalog number
98-1240L
Device description
Symmetry® Dissector, Medium Curved, Monopolar Handle w/Rotation, 5 mm, 45
Published
2018-09-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HFICoagulator, Culdoscopic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFICoagulator, Culdoscopic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K925114000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925114000LAPAROSCOPIC INSTRUMENTSEndo Technic Corp.1994-02-28HFI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482087053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482087053008874820870538874820870530887482087053

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
027680821
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841785112812Symmetry Olsen08-0089I08-0089I2018-05-22
00841785113321Symmetry Olsen08-009008-00902018-08-22
00887482139806Symmetry Malis®08-0089I08-0089I2016-05-24
00887482139820Symmetry Malis®08-009008-00902016-05-24
00841785112539Symmetry Olsen08-004508-00452017-11-02
00841785112805Symmetry Olsen08-008908-00892018-05-22
00841785113338Symmetry Olsen08-0047I08-0047I2018-08-22
00887482139547Symmetry Semkin08-004508-00452016-05-04
00887482139561Symmetry Hardy™08-0047I08-0047I2016-05-26
00887482139578Symmetry Surgical08-004808-00482016-05-26
00887482139653Symmetry Surgical08-005908-00592016-05-26
00887482139790Symmetry Malis®08-008908-00892016-05-17
00841785112317Symmetry Olsen08-0000I08-0000I2017-11-02
00841785112331Symmetry Olsen08-000108-00012017-11-02
00841785112348Symmetry Olsen08-0001I08-0001I2017-11-02
00841785112355Symmetry Olsen08-000408-00042017-11-02
00841785112362Symmetry Olsen08-0004I08-0004I2017-11-02
00841785112379Symmetry Olsen08-000508-00052017-11-02
00841785112393Symmetry Olsen08-000708-00072017-11-02
00841785112423Symmetry Olsen08-000908-00092017-11-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817401029048EndoplusEndoplusHFI2024-08-30
00817401028416EndoplusEndoplusHFI2022-07-08
00817401028423EndoplusEndoplusHFI2022-07-08
00817401028393EndoplusEndoplusHFI2022-03-10
00817401028140EndoplusEndoplusHFI2021-07-23
00817401027969EndoplusEndoplusHFI2021-05-26
00817401027976EndoplusEndoplusHFI2021-05-26
14042761086254OlympusOLYMPUS Winter & Ibe GmbHHFI2020-07-31
14042761086278OlympusOLYMPUS Winter & Ibe GmbHHFI2020-07-31
00817401027754EndoplusEndoplusHFI2020-06-26
00817401027495EndoplusEndoplusHFI2019-06-26
00887482032961Symmetry AllisASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482032978Symmetry AllisASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033036Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033135Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033289SymmetryASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033302Symmetry ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033326SymmetryASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033333Symmetry ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033371Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033388Symmetry ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033395Symmetry MixterASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033487SymmetryASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033531Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033609Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482033623Symmetry ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482062128Symmetry BabcockASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482074343Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482086193Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25
00887482086209Symmetry ASPEN SURGICAL PRODUCTS, INC.HFI2018-09-25