Medsurg Sterile Imaging Products
FDA 510(k) K934731 · Medsurg Industries, Inc.
510(k) numberK934731
Submission
- Device name
- Medsurg Sterile Imaging Products
- Applicant
- Medsurg Industries, Inc.
Herndon, VA, US - Received
- September 29, 1993
- Decision date
- March 28, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FMP – Protector, Skin Pressure
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6450
- Specialty
- General Hospital
Other 510(k)s with product code FMP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150243 | Invictus Medical GelShieldFMP · Traditional | Invictus Medical, Inc. | 05/01/2015SE |
| K951325 | Comfeel Plus Pressure Relief DressingFMP · Traditional | Richard Hamer Assoc., Inc. | 07/31/1995SE |
| K820584 | Decubicare Pads & AccessoriesFMP · Traditional | Abco Dealers, Inc. | 03/25/1982SE |
| K812344 | Heel or Elbow ProtectorFMP · Traditional | Fred Sammons, Inc. | 09/11/1981SE |
| K811184 | Spenco Dermal PadsFMP · Traditional | Spenco Medical Corp. | 05/20/1981SE |
| K802829 | Scanlan Vascu-StattFMP · Traditional | Scanlan Intl., Inc. | 01/15/1981SE |
| K802185 | Arterial Blood Sampling KitFMP · Traditional | Current Technologies, Inc. | 10/10/1980SE |
| K801694 | Flotation Pad for Operating TableFMP · Traditional | Action Products, Inc. | 08/27/1980SE |
| K801195 | Dermalex or Natrawool Skin Pressure ProtFMP · Traditional | Stock Wild & Co. | 06/09/1980SE |
| K792297 | Span Aids KitFMP · Traditional | American Hospital Supply Corp. | 12/20/1979SE |
More from American Hospital Supply Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K920780 | Medsurg Insertion TrayLFJ · Traditional | 08/19/1994SEKD |
| K940175 | Medsurg Sterile O.R. TowelsKKX · Traditional | 05/26/1994SE |
| K925558 | InfiltubeHIF · Traditional | 03/04/1994SE |
| K934971 | Sterile Laparotomy SpongesGDY · Traditional | 02/07/1994SE |
| K920421 | Medsurg Marshmallow TrayGAT · Traditional | 12/13/1993SESK |
| K920838 | Medsurg Circumcision TrayHFK · Traditional | 10/15/1993SE |
| K931932 | Dressing Change Tray-ModifiedMCY · Traditional | 08/27/1993SEKD |
| K914037 | Medsurg O.R. Procedure TrayLRO · Traditional | 06/22/1993SEKD |
| K914036 | Medsurg Laparoscopy TrayLRO · Traditional | 03/18/1992SE |
| K893938 | Continuous Epidural Anesthesia TrayCAZ · Traditional | 08/07/1989SE |
Questions and answers
When was Medsurg Sterile Imaging Products cleared by the FDA?
Medsurg Sterile Imaging Products (K934731) received a 510(k) decision of Substantially Equivalent on March 28, 1994, 180 days after the submission was received.
What is the product code of K934731?
The FDA product code is FMP – Protector, Skin Pressure, a Class I (low risk) device regulated under 21 CFR 880.6450.