Kidney Clamp
FDA 510(k) K890368 · Kinetic Medical Products
510(k) numberK890368
Submission
- Device name
- Kidney Clamp
- Applicant
- Kinetic Medical Products
Erie, PA, US - Received
- January 23, 1989
- Decision date
- February 3, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HXD – Clamp
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HXD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K890381 | Parametrium ClampHXD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890372 | Intestinal ClampHXD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K890371 | Intestinal Crushing ClampHXD · Traditional | Kinetic Medical Products | 02/03/1989SE |
| K874959 | Vascular ClampHXD · Traditional | Solway, Inc. | 12/30/1987SE |
| K872386 | C ClampHXD · Traditional | Med-Tool, Inc. | 07/02/1987SE |
| K863653 | Suction-OffHXD · Traditional | B&B Medical Technologies, Inc. | 10/07/1986SE |
| K853538 | Cannula ClampHXD · Traditional | Cp Medical | 09/12/1985SE |
| K851654 | Omnimed ClampHXD · Traditional | Omni Intl., Inc. | 05/31/1985SE |
| K801819 | Surgical InstrumentsHXD · Traditional | Robert I. Chien & Assoc., Inc. | 08/20/1980SE |
| K801028 | Rica or Smic Surgical InstrumentsHXD · Traditional | Robert I. Chien & Assoc., Inc. | 05/20/1980SE |
More from Robert I. Chien & Assoc., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K890385 | Midwifery/Obstetrical ForcepsHDA · Traditional | 03/01/1989SE |
| K890387 | Malleable Placenta CuretteHEX · Traditional | 02/27/1989SE |
| K890382 | Compression ForcepsHFW · Traditional | 02/27/1989SE |
| K890380 | Cervical Biopsy ForcepsHFB · Traditional | 02/27/1989SE |
| K890376 | Vaginal SpeculumHFD · Traditional | 02/27/1989SE |
| K890383 | Hysterectomy ForcepsHCZ · Traditional | 02/16/1989SE |
| K890216 | Microsurgical KeratomeGZX · Traditional | 02/16/1989SE |
| K890389 | Umbilical ScissorsHDJ · Traditional | 02/13/1989SE |
| K890388 | Cephalotomy ScissorsKNB · Traditional | 02/13/1989SE |
| K890386 | Placenta and Ovum ForcepsHCZ · Traditional | 02/13/1989SE |
Questions and answers
When was Kidney Clamp cleared by the FDA?
Kidney Clamp (K890368) received a 510(k) decision of Substantially Equivalent on February 3, 1989, 11 days after the submission was received.
What is the product code of K890368?
The FDA product code is HXD – Clamp, a Class I (low risk) device regulated under 21 CFR 878.4800.