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Aed

FDA UDI

Class II (US FDA UDI)

by National Advanced Endoscopy Devices, Inc.

Identity

Trade Name
AED FDA UDI
Generic Name
Flexible endoscopic tissue manipulation forceps, reusable FDA UDI
Device Name
Hystero Grasper Forcep FDA UDI
Model / Reference
HS2338 FDA UDI
Description
Hystero Grasper Forcep FDA UDI

Identifiers

Primary DI / UDI-DI
00848657066440 FDA UDI
510(k) Number
K141515 FDA UDI
FDA Product Code
HIH FDA UDI
GMDN Term
Flexible endoscopic tissue manipulation forceps, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.1690 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Aed by National Advanced Endoscopy Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K141515 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
National Advanced Endoscopy Devices, Inc.

Sources (1)

  • FDA UDI f9666f14-9d7a-46d5-9fba-11d583215ca1 35 fields · synced May 31, 2026