SUCTION-OFF
FDA 510(k) clearance K863653 · decided 1986-10-07
Clearance details
- K-number
- K863653
- Device name
- SUCTION-OFF
- Applicant
- B&B Medical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-09-18
- Decision date
- 1986-10-07
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- HXD
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Orangevale, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| KIDNEY CLAMP (K890368) | Kinetic Medical Products | 1989-02-03 |
| INTESTINAL CRUSHING CLAMP (K890371) | Kinetic Medical Products | 1989-02-03 |
| INTESTINAL CLAMP (K890372) | Kinetic Medical Products | 1989-02-03 |
| PARAMETRIUM CLAMP (K890381) | Kinetic Medical Products | 1989-02-03 |
| VASCULAR CLAMP (K874959) | Solway, Inc. | 1987-12-30 |
| C CLAMP (K872386) | Med-Tool, Inc. | 1987-07-02 |
| CANNULA CLAMP (K853538) | Cp Medical | 1985-09-12 |
| OMNIMED CLAMP (K851654) | Omni Intl., Inc. | 1985-05-31 |
| SURGICAL INSTRUMENTS (K801819) | Robert I. Chien & Assoc., Inc. | 1980-08-20 |
| RICA OR SMIC SURGICAL INSTRUMENTS (K801028) | Robert I. Chien & Assoc., Inc. | 1980-05-20 |
| GIZMO TOWEL CLAMP (K791289) | Hemoy, Inc. | 1979-07-24 |
| CLAMP, DISPOSABLE (K782090) | Concord Laboratories, Inc. | 1978-12-20 |
Recalls involving this device
No recalls on record reference this clearance.