Acu-E Punch

FDA 510(k) K933516 · Acuderm, Inc.

Substantially Equivalent

510(k) numberK933516

Submission

Device name
Acu-E Punch
Applicant
Acuderm, Inc.
Ft. Lauderdale, FL, US
Received
July 20, 1993
Decision date
March 24, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LRY – Punch, Surgical
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code LRY

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K904869Ellipse PunchLRY · Traditional Kramer Const03/06/1991SE
K902636Lipogen Rheumelisa Dsdna AssayLRY · Traditional Lipogen, Inc.06/28/1990SE
K896303Biopsy PunchLRY · Traditional Premier Medical02/13/1990SE
K874357Tapered PunchLRY · Traditional Med-Tool, Inc.11/23/1987SE
K874356Pin PunchLRY · Traditional Med-Tool, Inc.11/23/1987SE
K872388Nail SetLRY · Traditional Med-Tool, Inc.07/23/1987SE

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K930043Acu-EvacFYD · Traditional 02/09/1994SE
K933866Acu-Hemostatic RingMDM · Traditional 12/01/1993SE
K915000Acu-GuardGEX · Traditional 01/27/1992SE
K891334Acu-CuretteFZS · Traditional 04/11/1989SE
K874024Acu-Micro-NeedleFMI · Traditional 11/23/1987SE
K854877Acu-Syringe W/Wo NeedlesFMF · Traditional 02/19/1986SE
K832583Sabouraud Dextrose AgarJSJ · Traditional 09/12/1983SE
K832582Mycosel AgarJSJ · Traditional 09/12/1983SE

Questions and answers

When was Acu-E Punch cleared by the FDA?

Acu-E Punch (K933516) received a 510(k) decision of Substantially Equivalent on March 24, 1994, 247 days after the submission was received.

What is the product code of K933516?

The FDA product code is LRY – Punch, Surgical, a Class I (low risk) device regulated under 21 CFR 878.4800.