Dtad
FDA 510(k) K121678 · Gyrus Acmi, Inc.
510(k) numberK121678
Submission
- Device name
- Dtad
- Applicant
- Gyrus Acmi, Inc.
Southborough, MA, US - Received
- June 7, 2012
- Decision date
- August 30, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4250
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code ERL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro…ERL · Traditional | W&H Dentalwerk Buermoos GmbH | 07/03/2025SE |
| K233958 | hekaDrillERL · Traditional | Zethon, Ltd. | 03/14/2024SE |
| K221184 | ORiGO SystemERL · Traditional | Bien-Air Surgery SA | 11/02/2022SE |
| K213221 | AMADEO, M-UK1015 (incl. attachments and accessories)ERL · Traditional | W&H Dentalwerk Buermoss GmbH | 05/26/2022SE |
| K212650 | Celeris, Disposable Sinus DebriderERL · Traditional | Gyrus Acmi, Inc. | 01/19/2022SE |
| K211490 | Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number…ERL · Special | Stryker Corporation | 06/09/2021SE |
| K200318 | UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver HandpieceERL · Traditional | KARL STORZ Endoscopy-America, Inc. | 10/22/2020SE |
| K190715 | EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set…ERL · Traditional | Interscope, Inc. | 12/13/2019SE |
| K180063 | OCM-G1 AttachmentERL · Special | The Anspach Effort, Inc. | 03/27/2018SE |
| K171840 | Stryker Consolidated Operating Room Equipment (CORE) 2 ConsoleERL · Traditional | Stryker Corporation | 09/15/2017SE |
More from Stryker Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K252487 | POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA)GEI · Traditional | 03/02/2026SE |
| K233275 | RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use…FGB · Traditional | 03/25/2024SE |
| K231327 | POWERSEAL Sealer and DividerGEI · Traditional | 10/25/2023SE |
| K221306 | SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed…GEX · Traditional | 01/27/2023SE |
| K212650 | Celeris, Disposable Sinus DebriderERL · Traditional | 01/19/2022SE |
| K213831 | Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK NeedleGEI · Special | 01/04/2022SE |
| K211401 | SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser…GEX · Special | 06/03/2021SE |
| K181696 | ChitoZolveLYA · Traditional | 11/30/2018SE |
| K180086 | Gyrus ACMI EZDilate 3-Stage Balloon Dilatation CatheterFGE · Traditional | 03/08/2018SE |
| K171440 | Berkeley VC-10 Vacuum Curettage SystemHHI · Special | 09/29/2017SE |
Questions and answers
When was Dtad cleared by the FDA?
Dtad (K121678) received a 510(k) decision of Substantially Equivalent on August 30, 2012, 84 days after the submission was received.
What is the product code of K121678?
The FDA product code is ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, a Class II (moderate risk) device regulated under 21 CFR 874.4250.