Punch, Surgical

FDA product code LRY · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery

7510(k) clearances
0PMA approvals
6recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K933516Acu-E PunchLRY · Traditional Acuderm, Inc.03/24/1994SE
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

Recalls

RecallProductFirmInitiated
Z-0813-2018 Class IISurgical punch; sealed pouches packed in punch shelf box Intended for use by trained…Surgical punches are being recalled due to potential packaging damage which may have occurred during… Alto Development Corp10/23/2017Terminated
Z-0787-2016 Class IISIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in…Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause… DePuy Orthopaedics, Inc.01/08/2016Terminated
Z-1656-2013 Class IIARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.Due to lack of sterilization. Clorox Healthcare Holdings, LLC (dba…03/18/2013Terminated
Z-1655-2013 Class IIPSS Select medical products***Biopsy Punches*** Disposable manual instrument for skin…Due to lack of sterilization. Clorox Healthcare Holdings, LLC (dba…03/18/2013Terminated
Z-1654-2013 Class IIHealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.Due to lack of sterilization. Clorox Healthcare Holdings, LLC (dba…03/18/2013Terminated
Z-2399-2012 Class IIJUGGERKNOT INGUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be…Investigation found that the current design of the product allows the press-fit of the knob/shaft interface… Biomet, Inc.08/14/2012Terminated