MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP— 510(k) K070814
Substantially EquivalentConfluent Surgical,Inc
FDA 510(k) clearance K070814 for MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, Substantially Equivalent on 2007-05-30. Applicant: Confluent Surgical,Inc. Device class: 2.
Clearance details
- Applicant
- Confluent Surgical,Inc
- Product code
- Code FMF
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Waltham, MA, US
Recent devices under product code FMF
view allMore clearances from Confluent Surgical,Inc
view all- K091315 — COVIDIEN EXTENDED TIP APPLICATOR
- K072790 — CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008
- K061183 — CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093
- K050998 — CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063
- K042588 — CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093
Adverse events under product code FMF
product code FMF- Death
- 15
- Injury
- 2,263
- Malfunction
- 29,722
- Other
- 17
- Total
- 32,017
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.