DragonFly Surgical Drill System
FDA 510(k) K161376 · Grace Medical, Inc.
510(k) numberK161376
Submission
- Device name
- DragonFly Surgical Drill System
- Applicant
- Grace Medical, Inc.
Memphis, TN, US - Received
- May 18, 2016
- Decision date
- August 25, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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
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| K991394 | Stapes ProsthesesETB · Special | 05/18/1999SE |
Questions and answers
When was DragonFly Surgical Drill System cleared by the FDA?
DragonFly Surgical Drill System (K161376) received a 510(k) decision of Substantially Equivalent on August 25, 2016, 99 days after the submission was received.
What is the product code of K161376?
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.