OLYMPUS ENERGY POWER SYSTEM (EPS)— 510(k) K123429
Substantially EquivalentGyrus Acmi, Inc.
FDA 510(k) clearance K123429 for OLYMPUS ENERGY POWER SYSTEM (EPS), Substantially Equivalent on 2013-04-05. Applicant: Gyrus Acmi, Inc.. Device class: 2.
Clearance details
- Applicant
- Gyrus Acmi, Inc.
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Southborough, MA, US
Recent devices under product code GEI
view allMore clearances from Gyrus Acmi, Inc.
view all- K252487 — POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)
- K233275 — RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard) +2 more
- K231327 — POWERSEAL Sealer and Divider
- K221306 — SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories
- K212650 — Celeris, Disposable Sinus Debrider
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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 K123429
K-number listed on FDA's recall record- Z-1178-2019 — Olympus Diego Elite Console MDCONS 100
- Z-1179-2019 — Diego Elite Turbinate Blades:Bipolar Blade, 2mm straight, standard, type A Part No BB2000SA
- Z-1180-2019 — Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS
- Z-1181-2019 — Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC
- Z-1182-2019 — Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
- Z-1183-2019 — Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC
- Z-1184-2019 — Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS
- Z-1185-2019 — Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC
- Z-1186-2019 — Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS
- Z-1187-2019 — Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS
- Z-1752-2015 — Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head & Neck procedures. Catalog No. TS100S, Lot numbers JC929332 and below, Rx Only, STERILE EO
- Z-1753-2015 — Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head and Neck procedures. Catalog No. TS101DC, Lot numbers JC924165 and below; Rx Only, STERILE EO
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123429.
Data sourced from openFDA. This site is unofficial and independent of the FDA.