Rod, Irrigator, Supporting Telescoping, Type
FDA 510(k) K863688 · Brenner Metal Prod Corp.
510(k) numberK863688
Submission
- Device name
- Rod, Irrigator, Supporting Telescoping, Type
- Applicant
- Brenner Metal Prod Corp.
Wallington, NJ, US - Received
- September 19, 1986
- Decision date
- January 20, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FNJ – Bed, Manual
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5120
- Specialty
- General Hospital
Other 510(k)s with product code FNJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K934298 | King KribFNJ · Traditional | Noritage, Inc. | 01/26/1994SE |
| K892877 | Cradle, Hospital Bed ClothingFNJ · Traditional | Warsaw Orthopedic, Inc. | 06/15/1989SE |
| K885241 | Bed, Adjustable, Hospital, Folding, Field, W/O MatFNJ · Traditional | King Mfg. Co. | 02/24/1989SE |
| K884542 | Sic 3999 Folding Adjustable Hospital BedFNJ · Traditional | Commercial Products & Engineering Co. | 11/21/1988SE |
| K881725 | Envirotent (Bed)FNJ · Traditional | Envirotents, Inc. | 11/08/1988SE |
| K881961 | Msi Standard Bed Models: L1097-64 and L1085-64FNJ · Traditional | Med Service, Inc. | 11/01/1988SE |
| K881964 | Msi 3003 Series BedFNJ · Traditional | Med Service, Inc. | 06/28/1988SE |
| K881962 | Msi 2005 Series BedFNJ · Traditional | Med Service, Inc. | 06/03/1988SE |
| K881043 | Folding Hospital Cot NSN 6530-00-299-8517FNJ · Traditional | Junkin Safety Appliance Co., Inc. | 04/12/1988SE |
| K870166 | Platform Mattress W/Disposable Bedpan BagFNJ · Traditional | George C. Kuhn | 03/13/1987SE |
More from George C. Kuhn
| 510(k) | Device | Decision |
|---|---|---|
| K863694 | Bed/Adjust/Hospital/Folding Field Without MattressFNJ · Traditional | 01/20/1987SE |
| K863691 | Cot, Folding, Hospital, AluminumFNJ · Traditional | 01/20/1987SE |
| K863686 | Back Rest, Litter, Non-AdjustableFPP · Traditional | 01/20/1987SE |
| K863685 | Cart, Orthopedic Bed, StrykerFNJ · Traditional | 01/15/1987SE |
| K863690 | Stand, Irrigator, Steel, Folding · Traditional | 10/14/1986SE |
Questions and answers
When was Rod, Irrigator, Supporting Telescoping, Type cleared by the FDA?
Rod, Irrigator, Supporting Telescoping, Type (K863688) received a 510(k) decision of Substantially Equivalent on January 20, 1987, 123 days after the submission was received.
What is the product code of K863688?
The FDA product code is FNJ – Bed, Manual, a Class I (low risk) device regulated under 21 CFR 880.5120.