Trebay Irrgated Cutter Blade
FDA 510(k) K951526 · Trebay Medical Corp.
510(k) numberK951526
Submission
- Device name
- Trebay Irrgated Cutter Blade
- Applicant
- Trebay Medical Corp.
Clearwater, FL, US - Received
- April 3, 1995
- Decision date
- May 12, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EQJ – Bur, Ear, Nose And Throat
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4140
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code EQJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161514 | Precision Thin Reciprocating Blade, 0.010in.EQJ · Traditional | Stryker Corporation | 01/17/2017SE |
| K041985 | XPS Curved BurEQJ · Traditional | Medtronic Xomed, Inc. | 08/12/2004SE |
| K974232 | Essential Shaver SystemEQJ · Traditional | Gyrus Ent LLC | 01/12/1998SE |
| K960853 | Ace SystemEQJ · Traditional | Xomed, Inc. | 04/03/1996SE |
| K955704 | Trebay Microdebrider SystemEQJ · Traditional | Trebay Medical Corp. | 01/30/1996SE |
| K955294 | Sof - Abrasion BurEQJ · Traditional | Trebay Medical Corp. | 12/22/1995SE |
| K954912 | Trebay Irrigated Cutter Blade (Modification)EQJ · Traditional | Trebay Medical Corp. | 12/06/1995SE |
| K953370 | Karl Storz ENT ShaverEQJ · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/06/1995SE |
| K950337 | Karl Storz Stammberger-Sachse Intranasal-FrillEQJ · Traditional | KARL STORZ Endoscopy-America, Inc. | 08/23/1995SE |
| K952609 | Redi Drill Drill SystemEQJ · Traditional | Trebay Medical Corp. | 07/31/1995SE |
More from Trebay Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K955704 | Trebay Microdebrider SystemEQJ · Traditional | 01/30/1996SE |
| K955560 | Trebay Scope Irrigated Clearing SleeveEOB · Traditional | 12/22/1995SE |
| K955294 | Sof - Abrasion BurEQJ · Traditional | 12/22/1995SE |
| K955447 | Tympanostomy TubeETD · Traditional | 12/21/1995SE |
| K954912 | Trebay Irrigated Cutter Blade (Modification)EQJ · Traditional | 12/06/1995SE |
| K954795 | AT2 & Doyle Style (C-Flex) Vent TubesETD · Traditional | 11/15/1995SE |
| K954796 | Micro-Ingressor HandipieceERL · Traditional | 11/06/1995SE |
| K954715 | Micro-Planer HandpieceERL · Traditional | 10/27/1995SE |
| K954518 | Trebay Total Rectangular HeadETA · Traditional | 10/27/1995SE |
| K954517 | Trebay Partial Rectrangular Heads, Moretz Cam, Incus/Stapedial Joint & Straight Incus…ETB · Traditional | 10/27/1995SE |
Questions and answers
When was Trebay Irrgated Cutter Blade cleared by the FDA?
Trebay Irrgated Cutter Blade (K951526) received a 510(k) decision of Substantially Equivalent on May 12, 1995, 39 days after the submission was received.
What is the product code of K951526?
The FDA product code is EQJ – Bur, Ear, Nose And Throat, a Class I (low risk) device regulated under 21 CFR 874.4140.