# K121678: DTAD

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Aug 30, 2012 after 84 days
- Product code: ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece)
- Device class: 2
- Regulation: 21 CFR 874.4250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K936109 (1994). 93 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 96 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.
- K091223: Valleylab Suction Coagulator, Model E3305, Covidien LP (2009) Summary page 2.
- K082568: Saline Enhanced Electrosurgical Resection (Seer) Device, Bovie Medical (2008) Summary page 2.
- K083415: Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection Device, Peak Surgical, Inc. (2009) Summary page 2.

## Most influential descendants
- K123429: Olympus Energy Power System (Eps) (2013), 1 descendant of its own
- K212650: Celeris, Disposable Sinus Debrider (2022), 0 descendants of its own

## Indications for use
The DTAD is intended for cutting, coagulation, and removal of tissue in general ENT procedures. Specific indications include: Tonsillectomy and Adenoidectomy.

Source page: https://510kreport.com/device/K121678
Methodology: https://510kreport.com/methodology