Scalpel, One-Piece
FDA product code GDX · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
26510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Diverse Technologies, Inc. 1
- Surgistar, Inc. 1
- L.A.B. Instruments 1
- Oxboro Medical Intl., Inc. 1
- Kck Industries 1
- Precision Surgical Industries, Inc. 1
- Keisei Medical Industrial Co., Ltd. 1
- Medelec Intl. Corp. 1
- Medical Dimensions 1
- Artiberia 1
- Imm Enterprises , Ltd. 1
- Isolab, Inc. 1
- Lab Industries, Inc. 1
- Ascep, Inc. 1
- Narco Scientific 1
- Van-Tec, Inc. 1
- CooperVision, Inc. 1
- Abco Dealers, Inc. 1
- Neonatal Corp. 1
- Instrument Makar, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K923689 | Surgistar BladesGDX · Traditional | Surgistar, Inc. | 09/09/1992SE |
| K921167 | UltrabladeGDX · Traditional | Micron Technology, Inc. | 07/30/1992SE |
| K914086 | Ican Cylindrical SpongesGDX · Traditional | Icn Pharmaceuticals, Inc. | 10/09/1991SE |
| K904505 | Cci Corneal ScarifierGDX · Traditional | Buckman Co., Inc. | 04/23/1991SE |
| K905380 | 1-CUT Acl Graft KnifeGDX · Traditional | Depuy, Inc. | 12/13/1990SE |
| K895682 | Vessel LoopsGDX · Traditional | Applied Medical Technologies | 10/24/1989SE |
| K893033 | Mini-Diamond KnifeGDX · Traditional | L.A.B. Instruments | 05/26/1989SE |
| K880028 | Omed Disposable ScalpelGDX · Traditional | Oxboro Medical Intl., Inc. | 01/29/1988SE |
| K871894 | KCK Industries' Surgical InstrumentsGDX · Traditional | Kck Industries | 06/23/1987SE |
| K863950 | P.S.I.-Disposable Metal Handle Surgeons ScalpelGDX · Traditional | Precision Surgical Industries, Inc. | 10/24/1986SE |
| K863213 | Keisei Scalpel (Sterile and Non-Sterile)GDX · Traditional | Keisei Medical Industrial Co., Ltd. | 09/02/1986SE |
| K854857 | Scalpel, One-Piece, DisposableGDX · Traditional | Medelec Intl. Corp. | 12/24/1985SE |
| K853103 | McknifeGDX · Traditional | Medical Dimensions | 08/06/1985SE |
| K851751 | 7-120, 7-130,7-140, 7-150,9-151 to 168, 9-171 to 1GDX · Traditional | Artiberia | 06/20/1985SE |
| K834541 | H.R. Jakobi Surg. Instruments #9-SEC.48GDX · Traditional | Imm Enterprises , Ltd. | 01/27/1984SE |
| K833467 | Sure-CutGDX · Traditional | Diverse Technologies, Inc. | 01/27/1984SE |
| K830745 | Adt Disposable Scalpel W/Stainless SteelGDX · Traditional | Lab Industries, Inc. | 04/12/1983SE |
| K822893 | G.E.V. Disposable ScalpelsGDX · Traditional | Ascep, Inc. | 10/22/1982SE |
| K822749 | Pilling Diamond KnifeGDX · Traditional | Narco Scientific | 10/06/1982SE |
| K820869 | Disposable #11 Scalpel Blade W/ShortGDX · Traditional | Van-Tec, Inc. | 05/05/1982SE |
| K820730 | Micro Cise Diamond ScalpelGDX · Traditional | CooperVision, Inc. | 04/09/1982SE |
| K813422 | ScalpelGDX · Traditional | Abco Dealers, Inc. | 01/05/1982SE |
| K811707 | Axicut Disposable ScalpelGDX · Traditional | Neonatal Corp. | 07/20/1981SE |
| K800177 | I.M. BladesGDX · Traditional | Instrument Makar, Inc. | 02/11/1980SE |
| K790259 | Sterile Disposable KnifeGDX · Traditional | Intermedics, Inc. | 02/13/1979SE |
| K780998 | ScalpelGDX · Traditional | Isolab, Inc. | 07/27/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1892-2018 Class II | Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be used in…Scalpels lot contains non-sterile products labeled as sterile. | Southmedic, Inc. | 11/06/2017Terminated |
| Z-2800-2015 Class II | PenBlade Safety Scalpel, for the incision of human skin and tissue, and to cut or trim…Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk… | Zien Medical Technologies, Inc | 08/18/2015Terminated |
| Z-0891-2013 Class II | Technocut Plus, Sterile Single Use Safety Scalpel, Distributed by: Myco Medical.Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility. | Myco Medical Supplies Inc | 02/07/2013Terminated |
| Z-0990-2011 | Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0615, Size…Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. | Southmedic, Inc. | 09/03/2010Terminated |
| Z-0989-2011 | Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0611, Size…Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. | Southmedic, Inc. | 09/03/2010Terminated |
| Z-0988-2011 | Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0610, Size…Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile. | Southmedic, Inc. | 09/03/2010Terminated |