Mika Skin Scrub Tray Pre Operative W/Gel
FDA 510(k) K811087 · Cunningham Woodland, Inc.
510(k) numberK811087
Submission
- Device name
- Mika Skin Scrub Tray Pre Operative W/Gel
- Applicant
- Cunningham Woodland, Inc.
Mchenry, IL, US - Received
- April 21, 1981
- Decision date
- May 1, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FSM – Tray, Surgical, Instrument
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FSM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971217 | Instrument Tray LinerFSM · Traditional | General Hospital Supply Corp. | 05/06/1997SE |
| K962328 | Single Use Instrument TrayFSM · Traditional | Medcare Medical Group, Inc. | 08/09/1996SE |
| K944025 | Surgical Instrument TrayFSM · Traditional | Riley Medical, Inc. | 11/22/1994SE |
| K912106 | Arthroscopy TrayFSM · Traditional | Medical Device Inspection Co., Inc. | 08/29/1991SE |
| K912053 | Open Heart TrayFSM · Traditional | Medical Device Inspection Co., Inc. | 08/26/1991SE |
| K912052 | Heart Cath TrayFSM · Traditional | Medical Device Inspection Co., Inc. | 08/20/1991SE |
| K912104 | Major Basin TrayFSM · Traditional | Medical Device Inspection Co., Inc. | 08/09/1991SE |
| K910570 | Splinter TweezersFSM · Traditional | Solan Scissors Sales | 05/31/1991SE |
| K911601 | Reddick Trocar and CannulaFSM · Traditional | Ideal Medical, Inc. | 05/21/1991SE |
| K910328 | Key Comfort GripsFSM · Traditional | Key Surgical, Inc. | 03/06/1991SE |
More from Key Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K823527 | Subclavian Insertion KitFMF · Traditional | 03/31/1983SE |
| K813286 | Pre-Pack TENSGDY · Traditional | 01/22/1982SE |
| K813519 | Non-Absorbent TowelsKME · Traditional | 01/05/1982SE |
| K813284 | Venous Cannula TrayDWS · Traditional | 12/29/1981SE |
| K811091 | Minor Dressing TrayLDQ · Traditional | 05/08/1981SE |
| K811090 | Major Dressing TrayLDQ · Traditional | 05/08/1981SE |
| K811089 | One Step Prep KitLDQ · Traditional | 05/08/1981SE |
| K811088 | Dressing Tray Mercy HospitalLDQ · Traditional | 05/08/1981SE |
| K811086 | Suture Removal Set(Displsable)KDD · Traditional | 05/01/1981SE |
Questions and answers
When was Mika Skin Scrub Tray Pre Operative W/Gel cleared by the FDA?
Mika Skin Scrub Tray Pre Operative W/Gel (K811087) received a 510(k) decision of Substantially Equivalent on May 1, 1981, 10 days after the submission was received.
What is the product code of K811087?
The FDA product code is FSM – Tray, Surgical, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.