Blade, Scalpel
FDA 510(k) K854561 · Medelec Intl. Corp.
510(k) numberK854561
Submission
- Device name
- Blade, Scalpel
- Applicant
- Medelec Intl. Corp.
Miami Beach, FL, US - Received
- November 14, 1985
- Decision date
- December 2, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GES – Blade, Scalpel
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GES
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K032242 | Personna Plus Safety Scalpel SystemGES · Traditional | Omi Manufacturing Pty., Ltd. | 09/23/2003SE |
| K932998 | Easy-OnGES · Traditional | Devon Industries, Inc. | 08/18/1993SE |
| K923170 | Los Alamos Retractable KnifeGES · Traditional | Innovative Surgical Technology, Inc. | 02/18/1993SE |
| K915119 | Scalpel Blade Remover (Bladegard)GES · Traditional | Intergrated Visual, Inc. | 05/05/1992SE |
| K911913 | Precision Glide - Enhanced Surgical BladeGES · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/13/1991SE |
| K900266 | Sterile Carbon Steel Surgical BladeGES · Traditional | Rahn Laboratories | 03/01/1990SE |
| K884862 | Anchor Double-Edge Myringotomy BladeGES · Traditional | Anchor Products Co. | 12/27/1988SE |
| K881638 | Surgical BladeGES · Traditional | Far East Intl. Trading Corp. | 06/15/1988SE |
| K880244 | Surgical BladesGES · Traditional | Ailee C/O Havel'S, Inc. | 02/10/1988SE |
| K873493 | Ninja ScalpelGES · Traditional | Primrose Medical, Inc. | 09/24/1987SE |
More from Primrose Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K961013 | Disposable Needle ElectrodeIKT · Traditional | 12/20/1996SE |
| K935017 | TD50 ElectromyographJXE · Traditional | 07/28/1994SE |
| K922548 | Medelec 2110 and 2114 EEGGWQ · Traditional | 11/03/1992SE |
| K920127 | Electroencephalograph Recording SystemGWQ · Traditional | 06/10/1992SE |
| K912775 | Sapphire 4ME Emg/Ep SystemGWF · Traditional | 11/08/1991SE |
| K865106 | Prophylactic (Condom) Mr. JohnnyHIS · Traditional | 05/20/1987SE |
| K863491 | Blood Specimen Collection DevicesJKA · Traditional | 10/24/1986SE |
| K854622 | Prophylactic (Condom)HIS · Traditional | 04/11/1986SE |
| K854562 | Connector, Blood Tubing, Infusion T. Intravenous IBRZ · Traditional | 01/09/1986SE |
| K854860 | Blades, Scalpel Carbon SteetGES · Traditional | 12/24/1985SE |
Questions and answers
When was Blade, Scalpel cleared by the FDA?
Blade, Scalpel (K854561) received a 510(k) decision of Substantially Equivalent on December 2, 1985, 18 days after the submission was received.
What is the product code of K854561?
The FDA product code is GES – Blade, Scalpel, a Class I (low risk) device regulated under 21 CFR 878.4800.