FDA.reportPublic FDA data

LaproShear

Primary DI
00860006484811
Brand
LaproShear
Company
Surgical Principals, Inc
Model
120-7004
Device description
Laparoscopic Scissor 5mm 3/4 inch Metz Scissor Shaft, 45cm
Published
2024-11-19
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

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210569000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210569000Disposable Monopolar Laparoscopic Shafts and Reusable HandlesDannik, LLC2021-08-16GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860006484818PrimaryGS10
00860006484811Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000648481810860006484818
00860006484811008600064848118600064848110860006484811

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, monopolar, single-useAn electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a 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 requires a patient contact return electrode; it may include a suction/irrigation lumen and may feature a magnetic guidance sensor for electromagnetic tracking. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe) and may also be designed to mechanically cut tissues. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
782873892
Device count
10
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
true
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
10850067560316LaproSacEMP300-RGD-3EMP300-RGD-32026-05-22
10850067560231LaproSacEMP50-RGD-6EMP50-RGD-62026-04-10
10850067560156LaproSacEMP100-RGD-62026-01-12
10850067560163LaproSacEMP200-RGD-6EMP200-RGD-62026-01-12
10850067560248LaproSacEMP80-RGD-6EMP80-RGD-62026-01-12
10850067560132LaproSacEMP400-SPI-62026-01-09
10850067560149LaproSacEMP600-SPI-52026-01-09
00850067560135LaproSacEMP400-SPI-62026-01-09
00850067560142LaproSacEMP600-SPI-52026-01-09
10850067560170LaproCloseLCLOSE-100LCLOSE-1002025-12-11
10850067560187LaproCloseLCLOSE-200LCLOSE-2002025-12-11
10850067560194LaproCloseLCLOSE-300LCLOSE-3002025-12-11
10850067560224LaproClearLCLEAR-400LCLEAR-4002025-12-11
00850067560173LaproCloseLCLOSE-100LCLOSE-1002025-12-11
00850067560180LaproCloseLCLOSE-200LCLOSE-2002025-12-11
00850067560197LaproCloseLCLOSE-300LCLOSE-3002025-12-11
00850067560227LaproClearLCLEAR-400LCLEAR-4002025-12-11
10850067560002MaxRetract3316-8-SPI2025-10-23
10850067560019MaxRetract3316-1-SPI2025-10-23
10850067560026MaxRetract3350-8-SPI2025-10-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840319759042Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
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00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
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08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
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