FDA.reportPublic FDA data

AED Hystero Pro Fenestrated Grasper, 3mm x 36cm

Primary DI
00848657076104
Brand
AED Hystero Pro Fenestrated Grasper, 3mm x 36cm
Company
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
Model
H1301
Catalog number
H1301
Device description
A semi-rigid forcep inserted through the working channel of an endoscope to grasp tissue or other foreign bodies. It has a luer port for cleaning.
Published
2023-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIHHysteroscope (And Accessories)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141515000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141515000AED HYSTEROSCOPE AND ACCESSORIESNational Advanced Endoscopy Devices, Inc.2015-01-07HIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848657076104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848657076104008486570761048486570761040848657076104

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic tissue manipulation forceps, reusableA flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
8182272720customerservice@aed.md

Regulatory Flags#

DUNS number
839138955
Device count
1
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
00848657078535AEDAED2717B2026-10-20
00848657078542AEDAED2718B2026-10-20
00848657078559AEDAED2719B2026-10-20
00848657078481AED8815SB2026-10-08
00848657078498AED8810SB2026-10-08
00848657078504AED1010122026-10-08
00848657078511AED10121-A2026-10-08
00848657078528AEDAED26173AD2026-10-08
00848657083805AED1010162026-10-08
00848657083904AED1010012026-10-08
00848657078467AED101021-A2026-10-05
00848657078474AED101011-A2026-10-05
00848657083782AED1012112026-10-05
00848657083812AED1013112026-10-05
00848657083843AED1010662026-10-05
00848657083874AED1010002026-10-05
00848657083898AED1010212026-10-05
00848657084956AED101013T2026-10-05
00848657084963AED101066-L2026-10-05
00848657084970AED101066-S2026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00888937027501Endoscopic SealsCoopersurgical, Inc.HIH2026-10-22
00888937027556Endoscopic SealsCoopersurgical, Inc.HIH2026-10-22
00888937027563Endoscopic SealsCoopersurgical, Inc.HIH2026-10-22
00850006759507Aveta Cervical SealMEDITRINA, INC.HIH2026-10-05
00850083954154Resectr Resection Device 5FR (1.65 mm)Axora Medical, Inc.HIH2026-09-24
00850083954161Resectr Resection Device 9FR (3.0 mm)Axora Medical, Inc.HIH2026-09-24
00850083954352HERizon RD5 Resecting DeviceAxora Medical, Inc.HIH2026-09-24
06974880994053Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06974880994084Manual Tissue Removal DeviceSuzhou AcuVu medical technology Co., Ltd.HIH2026-07-27
06975339623418SeleneView®MacroLux Medical Technology Co., Ltd.HIH2026-07-03
00821925002104USA Elite SystemGyrus ACMI, LLCHIH2024-11-21
00821925002074USA Elite SystemGyrus ACMI, LLCHIH2024-07-25
00821925002562SlimLineGyrus ACMI, LLCHIH2024-07-24
07613327616675SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616682SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616699SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616705SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616712SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616729SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616736SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616743SPYSTRYKER CORPORATIONHIH2024-02-27
07613327624311NASTRYKER CORPORATIONHIH2024-02-27
07613327507102N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507119N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507126N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507133N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507140N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
08714729986935Cytuity™BOSTON SCIENTIFIC CORPORATIONHIH2019-08-20
10884521750203TruClearCovidien LPHIH2018-12-21