COVIDIEN EXTENDED TIP APPLICATOR— 510(k) K091315
Substantially EquivalentConfluent Surgical,Inc
FDA 510(k) clearance K091315 for COVIDIEN EXTENDED TIP APPLICATOR, Substantially Equivalent on 2009-06-05. 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- K072790 — CONFLUENT SURGICAL EXTENDED TIP APPLICATOR, MODEL 70-2008-008
- K070814 — MODIFICATION TO CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP
- 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 →
Recalls naming K091315
K-number listed on FDA's recall record- Z-1958-2025 — Extended Tip Applicator, 8CM, Box of 5.
- Z-1959-2025 — Extended Tip Applicator, 15 CM, Box of 5.
- Z-1960-2025 — Extended Tip Applicator 8CM, Box of 1.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091315.
Data sourced from openFDA. This site is unofficial and independent of the FDA.