SNIPER ELITE MODEL-OR-E3872XX SERIES— 510(k) K011905
Substantially EquivalentMaxxim Medical
FDA 510(k) clearance K011905 for SNIPER ELITE MODEL-OR-E3872XX SERIES, Substantially Equivalent on 2001-08-28. Applicant: Maxxim Medical. Device class: 2.
Clearance details
- Applicant
- Maxxim Medical
- Product code
- Code DQX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Athens, TX, US
Recent devices under product code DQX
view allMore clearances from Maxxim Medical
view all- K023236 — SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
- K021452 — STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE
- K002847 — INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX
- K010297 — SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)
- K002933 — STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES
Adverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
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.