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
00840113233762Bovie Derm 1022026-05-11
00607151010263BovieA1250SA1250S2018-02-23
00840113244232ValleylabE15594E155942026-05-04
00840113244249ValleylabE15596E155962026-05-04
00840113244256ValleylabE15604E156042026-05-04
00840113244263ValleylabE15606E156062026-05-04
00840113244270ValleylabE15614E156142026-05-04
00840113244287ValleylabE15616E156162026-05-04
00840113244294ValleylabE15624E156242026-05-04
00840113244300ValleylabE15626E156262026-05-04
00840113244317ValleylabE15644E156442026-05-04
00840113244324ValleylabE15646E156462026-05-04
00840113244331ValleylabE16512 E16512 2026-05-04
00840113244348ValleylabE16514E165142026-05-04
00887482188873BovieA23502024-09-27
00887482188897BovieA33502024-09-27
00887482181324BovieIDS-2102024-08-26
00887482181508BovieIDS-3102024-08-26
00887482182536BovieA9422024-08-26
00887482182550BovieA9522024-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00190776376109MillenniumAvalign Technologies, Inc.HIN2023-09-08
00190776377250MillenniumAvalign Technologies, Inc.HIN2023-09-08
00842180172012ELMEDELMED INCORPORATEDHIN2023-06-20