REPROCESSED STONE RETRIEVAL BASKETS— 510(k) K012581
Substantially EquivalentSterilmed, Inc.
FDA 510(k) clearance K012581 for REPROCESSED STONE RETRIEVAL BASKETS, Substantially Equivalent on 2002-02-14. Applicant: Sterilmed, Inc.. Device class: 2.
Clearance details
- Applicant
- Sterilmed, Inc.
- Product code
- Code FFL
- Device class
- Class 2
- Regulation
- 21 CFR 876.4680
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maple Grove, MN, US
Recent devices under product code FFL
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- K190478 — Reprocessed ViewFlex Xtra ICE Catheter
- K190610 — Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
- K182272 — Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis
Adverse events under product code FFL
product code FFL- Death
- 2
- Injury
- 270
- Malfunction
- 2,711
- Other
- 2
- Total
- 2,985
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.