The Porex Retractor Table
FDA 510(k) K860503 · Porex Medical
510(k) numberK860503
Submission
- Device name
- The Porex Retractor Table
- Applicant
- Porex Medical
Fairburn, GA, US - Received
- February 11, 1986
- Decision date
- March 13, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FSE – Table, Operating-Room, Manual
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4950
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FSE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K843801 | Mason Equipment Organizer & AspenFSE · Traditional | Aspen Laboratories, Inc. | 10/25/1984SE |
| K840027 | Operating Room StandFSE · Traditional | Healthmate, Inc. | 02/04/1984SE |
| K831042 | Chemonucleolysis Table ExtensionFSE · Traditional | Orthopedic Systems, Inc. | 05/16/1983SE |
| K830339 | Imsi/Metripond Hand Operating TableFSE · Traditional | Intl. Management Services, Inc. | 04/12/1983SE |
| K822427 | Self-Contained Mobile Ophthal. Oper. .FSE · Traditional | Surgi-Quip Inc.U | 09/14/1982SE |
| K821924 | Table, Operating, Field 6530-00-709-8155FSE · Traditional | Emerson-Sack-Warner Corp. | 07/13/1982SE |
| K801382 | Disposable Surgical Head SupportFSE · Traditional | Innovative Surgical Products, Inc. | 06/26/1980SE |
| K782092 | Armboard Cver, DisposableFSE · Traditional | Anago, Inc. | 01/10/1979SE |
| K780868 | Chest RollsFSE · Traditional | Devon Industries, Inc. | 08/14/1978SE |
| K780867 | Pad Holder KitFSE · Traditional | Devon Industries, Inc. | 08/14/1978SE |
More from Devon Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K872791 | Porex Nerve LocatorETN · Traditional | 10/20/1987SE |
| K873044 | Porex Otology InstrumentsLRC · Traditional | 09/04/1987SE |
| K872947 | Porex Quality Plastic Surgery InstrumentsKDG · Traditional | 08/21/1987SE |
| K863946 | Porex(Tm) Extra-Ocular Orbital ImplantHQX · Traditional | 02/27/1987SE |
| K863943 | Porex(Tm) Eye Sphere ImplantHPZ · Traditional | 02/27/1987SE |
| K870257 | Porex(Tm) Silicone Surgical Implants for E.N.T. · Traditional | 02/24/1987SE |
| K870182 | Porex(Tm) Malar Implant · Traditional | 02/24/1987SE |
| K870154 | Porex(Tm) Tissue ExpanderLCJ · Traditional | 02/24/1987SE |
| K863942 | Porex(Tm) Nose ProsthesisFZE · Traditional | 10/24/1986SE |
| K863941 | Porex(Tm) Prosthesis, Chin, InternalFWP · Traditional | 10/24/1986SE |
Questions and answers
When was The Porex Retractor Table cleared by the FDA?
The Porex Retractor Table (K860503) received a 510(k) decision of Substantially Equivalent on March 13, 1986, 30 days after the submission was received.
What is the product code of K860503?
The FDA product code is FSE – Table, Operating-Room, Manual, a Class I (low risk) device regulated under 21 CFR 878.4950.