ACKRAD ORAL SUCTION TUBE— 510(k) K854320
Substantially EquivalentAckrad Laboratories
FDA 510(k) clearance K854320 for ACKRAD ORAL SUCTION TUBE, Substantially Equivalent on 1986-01-10. Applicant: Ackrad Laboratories. Device class: 1.
Clearance details
- Applicant
- Ackrad Laboratories
- Product code
- Code BSY
- Device class
- Class 1
- Regulation
- 21 CFR 868.6810
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cranford, NJ, US
Recent devices under product code BSY
view allMore clearances from Ackrad Laboratories
view all- K021272 — SIB CATHETER, MODEL 61-7005
- K020954 — H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAY
- K020951 — H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007
- K970492 — INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
- K961752 — H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
Adverse events under product code BSY
product code BSY- Death
- 3
- Injury
- 155
- Malfunction
- 959
- Total
- 1,117
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.