LAPAROSHIELD CONDITIONED INSUFFLATION SET— 510(k) K030469
Substantially EquivalentPall Medical
FDA 510(k) clearance K030469 for LAPAROSHIELD CONDITIONED INSUFFLATION SET, Substantially Equivalent on 2003-05-09. Applicant: Pall Medical. Device class: 2.
Clearance details
- Applicant
- Pall Medical
- Product code
- Code HIF
- Device class
- Class 2
- Regulation
- 21 CFR 884.1730
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Recent devices under product code HIF
view allMore clearances from Pall Medical
view all- K033991 — MODIFICATION TO LAPAROSHIELD CONDITIONED INSUFFLATION SET
- K013093 — PALL ULTIPOR ANESTHESIA BREATHING SYSTEM
- K992361 — PALL SURGICLEAR LAPAROSCOPIC SMOKE FILTRATION SYSTEM, MODEL CLSF1
- K983735 — PALL DENTAL FILTRATION SYSTEM WITH AIR WATER SYRINGE HOUSING AND FILTER MEMBRANE
- K983731 — PALL DENTAL FILTRATION SYSTEM WITH INLINE HANDPIECE HOUSING AND FILTER MEMBRANE
Adverse events under product code HIF
product code HIF- Death
- 19
- Injury
- 578
- Malfunction
- 5,639
- Total
- 6,236
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.