Blackstar(Tm) Star System
FDA 510(k) K945659 · Xomed-Treace, Inc.
510(k) numberK945659
Submission
- Device name
- Blackstar(Tm) Star System
- Applicant
- Xomed-Treace, Inc.
Jacksonville, FL, US - Received
- November 17, 1994
- Decision date
- January 9, 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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More from Stryker Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K940028 | Endoscope SheathEOB · Traditional | 03/24/1995SE |
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| K932771 | Battery Powered, Disposable Endoscope Light SourceEQH · Traditional | 08/24/1994SE |
| K933672 | Xomed-Treace ScopesheathEOB · Traditional | 07/18/1994SE |
| K934426 | Nerve Integrity MONITOR-2 (NIM-2 XL)ETN · Traditional | 05/13/1994SE |
| K933105 | Xomed-Treace Rigid Rod Lens EndoscopeEOB · Traditional | 01/05/1994SE |
| K925640 | Xomed-Treace Emg Endotracheal TubeenETN · Traditional | 08/17/1993SE |
| K922880 | Xomed Treace Jet Ventilation TubeBTR · Traditional | 04/15/1993SE |
| K923830 | Xomed-Treace AlphascopeERA · Traditional | 11/09/1992SE |
| K912753 | Xomed-Treace Positrol Footpedal Suction ControlGCX · Traditional | 09/23/1991SE |
Questions and answers
When was Blackstar(Tm) Star System cleared by the FDA?
Blackstar(Tm) Star System (K945659) received a 510(k) decision of Substantially Equivalent on January 9, 1995, 53 days after the submission was received.
What is the product code of K945659?
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.