RK IV Surgical Blades
FDA 510(k) K812071 · Santa Barbara Medco, Inc.
510(k) numberK812071
Submission
- Device name
- RK IV Surgical Blades
- Applicant
- Santa Barbara Medco, Inc.
Mchenry, IL, US - Received
- July 21, 1981
- Decision date
- August 31, 1981
- 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 |
|---|---|---|
| K850492 | Nasal Septal ButtonLFB · Traditional | 03/07/1985SE |
| K842483 | Santa Barbara Medco-Lantophoretic ApplicEGJ · Traditional | 08/31/1984SE |
| K823921 | Physicians Choice Silicone Ear PuttyLDG · Traditional | 03/28/1983SE |
| K821187 | Medco Custom Ear Protector Mold KitEWD · Traditional | 05/27/1982SE |
| K812069 | Bores* Depth GaugeFTY · Traditional | 08/31/1981SE |
| K812070 | Bores* Adjustable Blade HolderGDZ · Traditional | 08/18/1981SE |
| K802638 | Otological Ventilation TubesETD · Traditional | 11/12/1980SE |
Questions and answers
When was RK IV Surgical Blades cleared by the FDA?
RK IV Surgical Blades (K812071) received a 510(k) decision of Substantially Equivalent on August 31, 1981, 41 days after the submission was received.
What is the product code of K812071?
The FDA product code is GES – Blade, Scalpel, a Class I (low risk) device regulated under 21 CFR 878.4800.