PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES
FDA 510(k) clearance K120065 · decided 2012-04-03
Clearance details
- K-number
- K120065
- Device name
- PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES
- Applicant
- Plaxtron Industrial (M) Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2012-01-09
- Decision date
- 2012-04-03
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- JCX
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Kaohsiung City, TW
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Plaxtron Industrial (M) Sdn. Bhd.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog recall (Z-1341-2026) | Laerdal Medical Corporation | 2026-02-11 |