Dyonics Disposable Endoscopic Surgery Blades
FDA 510(k) K954989 · Smith & Nephew Dyonics, Inc.
510(k) numberK954989
Submission
- Device name
- Dyonics Disposable Endoscopic Surgery Blades
- Applicant
- Smith & Nephew Dyonics, Inc.
Andover, MA, US - Received
- October 31, 1995
- Decision date
- November 27, 1995
- 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
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| K233958 | hekaDrillERL · Traditional | Zethon, Ltd. | 03/14/2024SE |
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| 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 |
|---|---|---|
| K955914 | Limited Reuse Arthroscopic BladesHRX · Traditional | 02/08/1996SE |
| K954627 | Ectra II Ligament Release SystemHRX · Traditional | 12/18/1995SN |
| K953695 | Dyonics Disposable Arthroscopic BladesHRX · Traditional | 09/15/1995SE |
| K953387 | Ectra Ligament Release SystemHRX · Traditional | 08/09/1995SE |
| K945182 | Dyonics Fixation ScrewsHWC · Traditional | 01/24/1995SN |
| K936071 | Smith & Nephew Dyonics Inc. Electronic EndoscopeHET · Traditional | 08/19/1994SE |
| K934299 | Dyonics Disposable Arthroscopic Surgery Blades ModificationHRX · Traditional | 02/14/1994SE |
| K920267 | Dyonics Arthroscopic KitLRO · Traditional | 03/23/1993SEKD |
| K922176 | Intelijet Suction SupplyBTA · Traditional | 11/18/1992SE |
| K914963 | Smith & Nephew Dyonics TMJ Arthroscopy Inflow SetHRX · Traditional | 06/04/1992SE |
Questions and answers
When was Dyonics Disposable Endoscopic Surgery Blades cleared by the FDA?
Dyonics Disposable Endoscopic Surgery Blades (K954989) received a 510(k) decision of Substantially Equivalent on November 27, 1995, 27 days after the submission was received.
What is the product code of K954989?
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.