Caspar Scalp Clip, Applier

FDA 510(k) K890443 · Aesculap Instruments Corp.

Substantially Equivalent

510(k) numberK890443

Submission

Device name
Caspar Scalp Clip, Applier
Applicant
Aesculap Instruments Corp.
Burlingame, CA, US
Received
January 27, 1989
Decision date
June 15, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HBO – Clip, Scalp
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4150
Specialty
Neurology

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K944311Acra-CutHBO · Traditional Acra Cut, Inc.11/18/1994SE
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K894778Codman RF-12 Disposable Scalp Clip ApplierHBO · Traditional Codman & Shurtleff, Inc.12/06/1989SE
K883963Raney and Leroy-Raney Scalp ClipHBO · Traditional New England Surgical Instrument Corp.10/07/1988SE
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Questions and answers

When was Caspar Scalp Clip, Applier cleared by the FDA?

Caspar Scalp Clip, Applier (K890443) received a 510(k) decision of Substantially Equivalent on June 15, 1989, 139 days after the submission was received.

What is the product code of K890443?

The FDA product code is HBO – Clip, Scalp, a Class II (moderate risk) device regulated under 21 CFR 882.4150.