# K123429: Olympus Energy Power System (Eps)

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Apr 5, 2013 after 149 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K936109 (1994). 96 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034004: Diego RF Powered Dissector and Drill System Console, Gyrus Ent LLC (2004) Summary page 2.
- K030343: Diego Powered Dissector Handpiece with Starlink Image-Guided Adapter Mounting Interface, Gyrus Ent LLC (2003) Summary page 2.
- K944602: Valleylab Force FX, Valleylab, Inc. (1995) Summary page 2.
- K121678: DTAD, Gyrus Acmi, Inc. (2012) Summary page 2.
- K011725: Olympus Suction Pump, Model KV-5, Keymed (Medical & Industrial Equipment), Ltd. (2001)

## Most influential descendants
- K212650: Celeris, Disposable Sinus Debrider (2022), 0 descendants of its own

## Recalls of this device
- Mar 8, 2019 · Class II · Z-1184-2019: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- Mar 8, 2019 · Class II · Z-1178-2019: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- Mar 8, 2019 · Class II · Z-1180-2019: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- Mar 8, 2019 · Class II · Z-1187-2019: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- Mar 8, 2019 · Class II · Z-1181-2019: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- Mar 8, 2019 · Class II · Z-1185-2019: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- Mar 8, 2019 · Class II · Z-1186-2019: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- Mar 8, 2019 · Class II · Z-1183-2019: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- Mar 8, 2019 · Class II · Z-1182-2019: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- Mar 8, 2019 · Class II · Z-1179-2019: Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
- May 8, 2015 · Class II · Z-1753-2015: Potential lack of sterility assurance.
- May 8, 2015 · Class II · Z-1752-2015: Potential lack of sterility assurance.

## Indications for use
The system, including Image Guided Surgery compatibility, and optional Suction console, is intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and bard tissue in general ENT, Sinus / Rhinology, Nasopharyngeal/ Laryngology, and Head & Neck procedures. Specific procedures and applications would include: Sinus / Rhinology: * FESS (Functional Endoscopic Sinus Surgery) o Including Endoscopic approaches to: Polypectomy, Ethmnoidectomly, Sphenoidectomy, Maxillary Antrostomy, Uncinectomy, Frontal Sinusotomy * Septal Spur removal * Endoscopic DCR * Trans-sphenoidal procedures specifically to create access through the sinuses to the Pituitary, Skull base, and CSF leak repair * Turbinate Reduction / Turbinoplasty oi Including sub mucosal resection Nasopharyngeal / Laryngeal: * Adenoidectomy / Tonsillectomy * Laryngeal procedures for Recurrent respiratory papilloma, Lesion de-bulking, Polypectomy Head & Neck: *Soft tissue shaving

Source page: https://510kreport.com/device/K123429
Methodology: https://510kreport.com/methodology