FDA.reportPublic FDA data

Symmetry Surgical

Primary DI
00887482128596
Brand
Symmetry Surgical
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
90-1013
Device description
Handle, 5.0 mm Thumb Ring Handle, Kleppinger Type, 31.7 cm
Published
2024-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113080000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113080000TUBALGATORMectra Labs, Inc.2012-06-29HIN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482128596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482128596008874821285968874821285960887482128596

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic surgery handleA hand-held manual surgical instrument intended to be used during laparoscopy to perform a variety of surgical manipulations with various attachable tips/ends; it does not facilitate irrigation or aspiration (suction). It is typically made of metal and/or synthetic material with a straight handle grip. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length31.7Centimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 888-364-7004customerservice@symmetrysurgical.com

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
00887482121078Symmetry Dingman67-591167-59112024-08-20
00887482121085Symmetry Dingman67-591267-59122024-08-20
00840113234356BovieA1204C2026-08-17
10840113234728Bovie00032026-08-17
10840113237705BovieESP62026-08-17
10840113237712BovieESP1HN2026-08-17
10840113242426Bovie00022026-08-17
10840113244635Bovie00012026-08-17
10607151008328BovieBVX-LL06T-NSBVX-LL06T-NS2016-09-13
10607151008335BovieBVX-LC04T-NSBVX-LC04T-NS2016-09-13
10607151008342BovieBVX-LB02T-NSBVX-LB02T-NS2016-09-13
10607151008366BovieBVX-LJ07T-NSBVX-LJ07T-NS2016-09-13
10607151008373BovieBVX-LH08T-NSBVX-LH08T-NS2016-09-13
10607151008380BovieBVX-LH01T-NSBVX-LH01T-NS2016-09-13
10607151008397BovieBVX-LN03T-NSBVX-LN03T-NS2016-09-13
10607151011267BovieCS-103T-SDVCS-103T-SDV2016-08-29
10607151011281BovieCS-103T-SVCS-103T-SV2016-08-29
10607151011304BovieCS103T-SVMCS103T-SVM2016-08-29
10607151011311BovieCS-105LEDCS-105LED2016-08-29
10607151011328BovieCS-105T-LEDCS-105T-LED2016-08-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427986MillenniumAvalign Technologies, Inc.HIN2026-08-27
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00198506089381ELMED INCORPORATEDELMED INCORPORATEDHIN2026-04-02
05708265016389LiNA Bipolar Loop™LiNA Medical AGHIN2026-04-02
05708265016402LiNA Bipolar Loop™LiNA Medical AGHIN2026-04-02
05708265016426LiNA Bipolar Loop™LiNA Medical AGHIN2026-04-02
B382SD80055210Surgical DirectSurgical Direct, Inc.HIN2026-02-12
00842180135437ELMED INCORPORATEDELMED INCORPORATEDHIN2025-09-29
00842180135475ELMED INCORPORATEDELMED INCORPORATEDHIN2025-09-29
00198506026027ELMED INCORPORATEDELMED INCORPORATEDHIN2025-05-22
00198506026034ELMED INCORPORATEDELMED INCORPORATEDHIN2025-03-11
00198506020841ELMED INCORPORATEDELMED INCORPORATEDHIN2025-03-05
06976860690375ClearVisionOriGyn Medical Technology (Hangzhou) Co., Ltd.HIN2024-09-23
06976860690382ClearVisionOriGyn Medical Technology (Hangzhou) Co., Ltd.HIN2024-09-23
06976860690399ClearVisionOriGyn Medical Technology (Hangzhou) Co., Ltd.HIN2024-09-23
06976860690405ClearVisionOriGyn Medical Technology (Hangzhou) Co., Ltd.HIN2024-09-23
00887482128602Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HIN2024-09-09
00198506060731ELMED INCORPORATEDELMED INCORPORATEDHIN2024-08-26
00190776126421MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776126438MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776127121MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776127152MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776127190MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776127626MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776127817MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776131661MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776142476MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776381851MillenniumAvalign Technologies, Inc.HIN2023-11-13
00190776376093MillenniumAvalign Technologies, Inc.HIN2023-09-08