Aspen® Endoscopic Kittner, Single Tip

FDA UDI

Class II (US FDA UDI)

by Aspen Surgical Products, Inc.

Identity

Trade Name: Aspen® Endoscopic Kittner, Single Tip FDA UDI
Generic Name: Dissection sponge FDA UDI
Device Name: This product is single use and intended to be used for blunt dissection of tissue. FDA UDI
Model / Reference: KT-9101 FDA UDI
Description: This product is single use and intended to be used for blunt dissection of tissue. FDA UDI

Identifiers

Primary DI / UDI-DI: 00840113214006 FDA UDI
510(k) Number: K913500 FDA UDI
FDA Product Code: GCJ FDA UDI
GMDN Term: Dissection sponge 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dissection sponge

Aspen® Endoscopic Kittner, Single Tip by Aspen Surgical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K913500 also covers:

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: Aspen Surgical Products, Inc.

Sources (1)

FDA UDI ef9709c9-10b5-4328-a91f-8e739b393eeb 35 fields · synced Jun 9, 2026