DIEGO ELITE DRILL— 510(k) K152744
Substantially EquivalentGyrus Acmi, Inc.
FDA 510(k) clearance K152744 for DIEGO ELITE DRILL, Substantially Equivalent on 2016-06-10. Applicant: Gyrus Acmi, Inc.. Device class: 2.
Clearance details
- Applicant
- Gyrus Acmi, Inc.
- Product code
- Code ERL
- Device class
- Class 2
- Regulation
- 21 CFR 874.4250
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Southborough, MA, US
Recent devices under product code ERL
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
- K213831 — Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle
Adverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.