57810A AED 8mm x 0 Degree x 17cm Endoscope

FDA UDI

Class II (US FDA UDI)

by National Advanced Endoscopy Devices, Inc.

Identity

Trade Name: 57810A AED 8mm x 0 Degree x 17cm Endoscope FDA UDI
Generic Name: Rigid optical reconstructive surgery endoscope FDA UDI
Device Name: An endoscope with a rigid inserted portion intended to be used in plastic surgery for reconstructive operations, the suction of subcutaneous tissue, or vein harvesting. FDA UDI
Model / Reference: 57810A FDA UDI
Description: An endoscope with a rigid inserted portion intended to be used in plastic surgery for reconstructive operations, the suction of subcutaneous tissue, or vein harvesting. FDA UDI

Identifiers

Catalog Number: 57810A FDA UDI
Primary DI / UDI-DI: 00848657069458 FDA UDI
510(k) Number: K993688 FDA UDI
FDA Product Code: GCJ FDA UDI
GMDN Term: Rigid optical reconstructive surgery endoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Rigid optical reconstructive surgery endoscope

57810A AED 8mm x 0 Degree x 17cm Endoscope by National Advanced Endoscopy Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID

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Also classified as Rigid optical reconstructive surgery endoscope.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: National Advanced Endoscopy Devices, Inc.

Sources (1)

FDA UDI 5c0740b2-e10c-494b-9d6b-915a4cda87e8 36 fields · synced Jun 8, 2026

57810A AED 8mm x 0 Degree x 17cm Endoscope

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)