Handle, Scalpel
FDA product code GDZ · Class I (low risk) · 21 CFR 878.4800 · General, Plastic Surgery
16510(k) clearances
0PMA approvals
13recalls
Manufacturers
- The Huxley Instrument Corp. 2
- Parke-Davis Co. 1
- Instrument Makar, Inc. 1
- Santa Barbara Medco, Inc. 1
- Zee Medical Products Co., Inc. 1
- M-W Laboratories, Inc. 1
- Brimfield Scientific Instruments 1
- Artiberia 1
- Medelec Intl. Corp. 1
- Keisei Medical Industrial Co., Ltd. 1
- S. Cordero Co. 1
- Precision Surgical Industries, Inc. 1
- Bd Becton Dickinson Vacutainer Systems Preanalytic 1
- Kinetic Medical Products 1
- Spectra, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091462 | Spectra Medical Safety ScapelGDZ · Traditional | Spectra, Inc. | 12/15/2009SE |
| K890242 | Scalpel HandleGDZ · Traditional | Kinetic Medical Products | 01/27/1989SE |
| K884512 | Beaver(R) HandleGDZ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 11/17/1988SE |
| K863951 | P.S.I.-Disposable Scalpel Surgeons HandleGDZ · Traditional | Precision Surgical Industries, Inc. | 10/24/1986SE |
| K863808 | The S. Cordero StylusGDZ · Traditional | S. Cordero Co. | 10/14/1986SE |
| K863212 | Keisei Handles for Surgical BladesGDZ · Traditional | Keisei Medical Industrial Co., Ltd. | 09/02/1986SE |
| K854858 | Scalpel HandleGDZ · Traditional | Medelec Intl. Corp. | 12/24/1985SE |
| K852735 | Scalpel Handle #7 SS 410 or 420GDZ · Traditional | The Huxley Instrument Corp. | 07/15/1985SE |
| K852711 | Scalpel Handle #3 SS 410 or 420GDZ · Traditional | The Huxley Instrument Corp. | 07/15/1985SE |
| K851750 | 7-103, 7-104, 7-107 Scalpel Handles, #3 #4 #7GDZ · Traditional | Artiberia | 06/20/1985SE |
| K852042 | Brimfield Cannulated Blade HolderGDZ · Traditional | Brimfield Scientific Instruments | 06/11/1985SE |
| K812876 | Surgical PawsGDZ · Traditional | M-W Laboratories, Inc. | 11/20/1981SE |
| K812814 | Zee Surgical InstrumentsGDZ · Traditional | Zee Medical Products Co., Inc. | 11/06/1981SE |
| K812070 | Bores* Adjustable Blade HolderGDZ · Traditional | Santa Barbara Medco, Inc. | 08/18/1981SE |
| K810720 | I.M. Scalpel HandleGDZ · Traditional | Instrument Makar, Inc. | 04/03/1981SE |
| K761035 | Surgical Blade HandlesGDZ · Traditional | Parke-Davis Co. | 12/21/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0937-2025 Class II | ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC…Reports of various packaging issues that may result in a breach of the sterile barrier. | Sklar Instruments | 12/03/2024Open, Classified |
| Z-1436-2024 Class II | Centurion scalpel handle kits labeled as: a) STERILE # 3 SCALPEL HANDLE, Product Code…Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails.… | MEDLINE INDUSTRIES, LP - Northfield | 02/23/2024Open, Classified |
| Z-0079-2023 Class II | Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could… | Steris Corporation | 09/02/2022Terminated |
| Z-1841-2016 Class II | Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical…One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in… | Integra York PA, Inc | 03/11/2016Terminated |
| Z-0039-2018 Class II | Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF…The knife handles slot depth is out of specification, so blades may not fit on the handles properly. | Teleflex Medical | 09/26/2014Completed |
| Z-1443-2015 Class II | Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing…Potential for inadvertent scalpel stick injury involving the safety scalpel. | Bard Access Systems | 06/24/2014Terminated |
| Z-0641-2014 Class II | Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety Handle…Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety… | Ansell Sandel Medical Industries LLC | 11/12/2013Terminated |
| Z-0640-2014 Class II | Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety…Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety… | Ansell Sandel Medical Industries LLC | 11/12/2013Terminated |
| Z-0639-2014 Class II | Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle…Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety… | Ansell Sandel Medical Industries LLC | 11/12/2013Terminated |
| Z-0638-2014 Class II | Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle…Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety… | Ansell Sandel Medical Industries LLC | 11/12/2013Terminated |
| Z-0637-2014 Class II | Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety…Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety… | Ansell Sandel Medical Industries LLC | 11/12/2013Terminated |
| Z-0636-2014 Class II | Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle…Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety… | Ansell Sandel Medical Industries LLC | 11/12/2013Terminated |
| Z-0635-2014 Class II | Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle…Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety… | Ansell Sandel Medical Industries LLC | 11/12/2013Terminated |