Surgiclean Enzymatic Instrument Cleaner
FDA 510(k) K931270 · Surgicot, Inc.
510(k) numberK931270
Submission
- Device name
- Surgiclean Enzymatic Instrument Cleaner
- Applicant
- Surgicot, Inc.
Research Triangle Park, NC, US - Received
- March 8, 1993
- Decision date
- April 13, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FLG – Cleaner, Ultrasonic, Medical Instrument
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6150
- Specialty
- General Hospital
Other 510(k)s with product code FLG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944950 | KlenzymeFLG · Traditional | Calgon Corp. | 12/20/1994SE |
| K944494 | Alsa-KlenzFLG · Traditional | Calgon Vestal Div. | 10/19/1994SE |
| K944033 | Bill Evans-KlenzFLG · Traditional | Calgon Vestal Div. | 10/07/1994SE |
| K941163 | Mon-KlenzFLG · Traditional | Calgon Vestal Div. | 05/18/1994SE |
| K940263 | Nph-KlenzFLG · Traditional | Calgon Corp. | 05/18/1994SE |
| K935063 | Instru KlenzFLG · Traditional | Calgon Corp. | 05/09/1994SE |
| K934666 | PDS UltracleanFLG · Traditional | Medical Polymers, Inc. | 04/15/1994SE |
| K933149 | Instrument Detergent ConcentrateFLG · Traditional | Nobelpharma USA, Inc. | 02/16/1994SE |
| K884660 | Biosonic Ultrasonic Cleaning SystemFLG · Traditional | Whaledent Intl. Div. Ipco | 03/16/1989SE |
| K862282 | Rapidex Biological SurfactantFLG · Traditional | Rapidex of London | 05/11/1987SE |
More from Rapidex of London
| 510(k) | Device | Decision |
|---|---|---|
| K962605 | Pro-Guard Double-Duty Sterilization Wrap (Single Use)FRG · Traditional | 03/11/1997SE |
| 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 |
| K840470 | Surgiscribe Marking PenFZZ · Traditional | 03/12/1984SE |
| K830739 | Pro-GuardFRG · Traditional | 03/29/1983SE |
| K820302 | Surgipeel Self-Seal Packaging SystemFRG · Traditional | 02/24/1982SE |
Questions and answers
When was Surgiclean Enzymatic Instrument Cleaner cleared by the FDA?
Surgiclean Enzymatic Instrument Cleaner (K931270) received a 510(k) decision of Substantially Equivalent on April 13, 1994, 401 days after the submission was received.
What is the product code of K931270?
The FDA product code is FLG – Cleaner, Ultrasonic, Medical Instrument, a Class I (low risk) device regulated under 21 CFR 880.6150.