Surgiscribe Marking Pen
FDA 510(k) K840470 · Surgicot, Inc.
510(k) numberK840470
Submission
- Device name
- Surgiscribe Marking Pen
- Applicant
- Surgicot, Inc.
Mchenry, IL, US - Received
- February 3, 1984
- Decision date
- March 12, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FZZ – Marker, Skin
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4660
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FZZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K042555 | Surgichip Tag Surgical MarkerFZZ · Traditional | Surgichip, Inc. | 11/09/2004SE |
| K915066 | Disposable Skin MarkerFZZ · Traditional | American Medical Mfg., Inc. | 05/14/1992SE |
| K914759 | Bloom Transparent StencilFZZ · Traditional | Freckles Publications, Inc. | 04/21/1992SE |
| K912730 | Rocket Surgical Skin Marking PenFZZ · Traditional | West Texas Lighthouse For the Blind | 11/07/1991SE |
| K905143 | Skin MarkerFZZ · Traditional | Aesculap, Inc. | 02/06/1991SE |
| K904559 | Qualtex Skin MarkerFZZ · Traditional | Qualtex, Inc. | 12/13/1990SE |
| K896792 | Surgical Skin MarkerFZZ · Traditional | Westmark, Sterile Packing Systems, Inc. (Sps) | 12/27/1989SE |
| K864371 | Surgical Skin MarkerFZZ · Traditional | Myocure, Inc. | 11/17/1986SE |
| K863280 | DermamarkerFZZ · Traditional | Dermacare Products, Inc. | 09/09/1986SE |
| K861772 | Laser Skin Marker and Mask White LotionFZZ · Traditional | Pacific Poly Crafts | 05/21/1986SE |
More from Pacific Poly Crafts
| 510(k) | Device | Decision |
|---|---|---|
| K962605 | Pro-Guard Double-Duty Sterilization Wrap (Single Use)FRG · Traditional | 03/11/1997SE |
| K931270 | Surgiclean Enzymatic Instrument CleanerFLG · Traditional | 04/13/1994SE |
| K863122 | Assert Biological/Chemical Indicator 12 Month Exp.FRC · Traditional | 12/17/1986SE |
| K855101 | Assert TM Biological/Chemical IndicatorFRC · Traditional | 07/17/1986SE |
| K854631 | Assert Eo Biological Test PackFRC · Traditional | 05/27/1986SE |
| K854902 | Surgicot Steam Test PackFRC · Traditional | 05/20/1986SE |
| K840541 | Neuro SpongeGDY · Traditional | 04/23/1984SE |
| K840471 | Eye SpearHOZ · Traditional | 03/16/1984SE |
| K830739 | Pro-GuardFRG · Traditional | 03/29/1983SE |
| K820302 | Surgipeel Self-Seal Packaging SystemFRG · Traditional | 02/24/1982SE |
Questions and answers
When was Surgiscribe Marking Pen cleared by the FDA?
Surgiscribe Marking Pen (K840470) received a 510(k) decision of Substantially Equivalent on March 12, 1984, 38 days after the submission was received.
What is the product code of K840470?
The FDA product code is FZZ – Marker, Skin, a Class I (low risk) device regulated under 21 CFR 878.4660.