ONE STEP BUTTON(TM)— 510(k) K910584
Substantially EquivalentApplied Medical Technologies
FDA 510(k) clearance K910584 for ONE STEP BUTTON(TM), Substantially Equivalent on 1991-05-23. Applicant: Applied Medical Technologies. Device class: 2.
Clearance details
- Applicant
- Applied Medical Technologies
- Product code
- Code KGC
- Device class
- Class 2
- Regulation
- 21 CFR 876.5980
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Independence, OH, US
Recent devices under product code KGC
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- K971757 — LOW PROFILE FEEDING SET ACCESSORY
- K971758 — CAUTERIZATION SMOKE EVACUATOR
Adverse events under product code KGC
product code KGC- Death
- 7
- Total
- 7
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 K910584
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 K910584.
Data sourced from openFDA. This site is unofficial and independent of the FDA.