Precision Thin Reciprocating Blade, 0.010in.
FDA 510(k) K161514 · Stryker Corporation
510(k) numberK161514
Submission
- Device name
- Precision Thin Reciprocating Blade, 0.010in.
- Applicant
- Stryker Corporation
Kalamazoo, MI, US - Received
- June 2, 2016
- Decision date
- January 17, 2017
- 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
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|---|---|---|---|
| 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 |
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| 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 |
| K953096 | Essential Shaver SystemEQJ · Traditional | Smith & Nephew Richards, Inc. | 07/28/1995SE |
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Questions and answers
When was Precision Thin Reciprocating Blade, 0.010in. cleared by the FDA?
Precision Thin Reciprocating Blade, 0.010in. (K161514) received a 510(k) decision of Substantially Equivalent on January 17, 2017, 229 days after the submission was received.
What is the product code of K161514?
The FDA product code is EQJ – Bur, Ear, Nose And Throat, a Class I (low risk) device regulated under 21 CFR 874.4140.