AQUACEL Ag Surgical SP Dressing— 510(k) K152926
Substantially EquivalentConvatec Limited
FDA 510(k) clearance K152926 for AQUACEL Ag Surgical SP Dressing, Substantially Equivalent on 2016-01-21. Applicant: Convatec Limited. Device class: Unclassified.
Clearance details
- Applicant
- Convatec Limited
- Product code
- Code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Deeside, GB
Recent devices under product code FRO
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view all- K252943 — GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women
- K250891 — Cure Catheter Insertion Kit (K1) +12 more
- K213283 — GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter
- K190114 — Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)
- K180205 — AVELLE Negative Pressure Wound Therapy System
Adverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
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 K152926
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152926.
Data sourced from openFDA. This site is unofficial and independent of the FDA.