Suction-Off
FDA 510(k) K863653 · B&B Medical Technologies, Inc.
510(k) numberK863653
Submission
- Device name
- Suction-Off
- Applicant
- B&B Medical Technologies, Inc.
Orangevale, CA, US - Received
- September 18, 1986
- Decision date
- October 7, 1986
- 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 |
| 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 |
|---|---|---|
| K030396 | Omni~Neb; Omni~MaxCAF · Traditional | 05/07/2004SE |
| K980407 | Hope NebulizerCAF · Traditional | 05/27/1998SE |
| K960663 | Universal Bite BlockJXL · Traditional | 05/17/1996SE |
| K945816 | Quick-LockBTR · Traditional | 01/13/1995SE |
| K944324 | Sure-Lock Ventilator Tubing HolderBTR · Traditional | 11/04/1994SE |
| K935171 | StabiltrachCBH · Traditional | 12/02/1993SE |
| K925386 | Adhesive E.T. TapeCBH · Traditional | 04/19/1993SESK |
| K923690 | Mini HeartCAF · Traditional | 10/20/1992SE |
| K913015 | Heart Nebulizer Flowmeter AdaptorCAF · Traditional | 11/20/1991SE |
| K913753 | Bodai NEO2 -Safe Airway Pressure CapCAI · Traditional | 10/23/1991SE |
Questions and answers
When was Suction-Off cleared by the FDA?
Suction-Off (K863653) received a 510(k) decision of Substantially Equivalent on October 7, 1986, 19 days after the submission was received.
What is the product code of K863653?
The FDA product code is HXD – Clamp, a Class I (low risk) device regulated under 21 CFR 878.4800.