Rica or Smic Surgical Instruments
FDA 510(k) K801028 · Robert I. Chien & Assoc., Inc.
510(k) numberK801028
Submission
- Device name
- Rica or Smic Surgical Instruments
- Applicant
- Robert I. Chien & Assoc., Inc.
Mchenry, IL, US - Received
- May 1, 1980
- Decision date
- May 20, 1980
- 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 |
| K890368 | Kidney 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 |
More from Robert I. Chien & Assoc., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K822151 | Surgical Instruments Represent. 4 ClassHNF · Traditional | 08/19/1982SE |
| K811632 | Unsterilized Laparotomy Sponges (China)GDY · Traditional | 09/11/1981SE |
| K811631 | Thermometer (Made in China)FLK · Traditional | 07/20/1981SE |
| K810054 | Rica (Diagnostic Instruments)GWZ · Traditional | 01/28/1981SE |
| K801819 | Surgical InstrumentsHXD · Traditional | 08/20/1980SE |
Questions and answers
When was Rica or Smic Surgical Instruments cleared by the FDA?
Rica or Smic Surgical Instruments (K801028) received a 510(k) decision of Substantially Equivalent on May 20, 1980, 19 days after the submission was received.
What is the product code of K801028?
The FDA product code is HXD – Clamp, a Class I (low risk) device regulated under 21 CFR 878.4800.