Karl Storz ENT Shaver
FDA 510(k) K953370 · KARL STORZ Endoscopy-America, Inc.
510(k) numberK953370
Submission
- Device name
- Karl Storz ENT Shaver
- Applicant
- KARL STORZ Endoscopy-America, Inc.
Culver City, CA, US - Received
- July 18, 1995
- Decision date
- September 6, 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 |
| 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 |
More from Smith & Nephew Richards, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252624 | KARL STORZ Laryngoscopes and AccessoriesEQN · Traditional | 05/15/2026SE |
| K240506 | KARL STORZ HoldersOCV · Traditional | 10/22/2024SE |
| K223885 | HOPKINS TelescopesHIH · Traditional | 09/14/2023SE |
| K230359 | KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP)…GCJ · Traditional | 06/23/2023SE |
| K223520 | UNIDRIVE SIII SystemHIH · Traditional | 04/27/2023SE |
| K223923 | HOPKINS TelescopesGCJ · Traditional | 03/30/2023SE |
| K221893 | KARL STORZ Bipolar Resectoscopes with HF CableFJL · Traditional | 03/17/2023SE |
| K221004 | HOPKINS TelescopesGCJ · Traditional | 12/20/2022SE |
| K222504 | H1GCJ · Traditional | 11/10/2022SE |
| K213194 | HD MediastinoscopeEWY · Traditional | 06/23/2022SE |
Questions and answers
When was Karl Storz ENT Shaver cleared by the FDA?
Karl Storz ENT Shaver (K953370) received a 510(k) decision of Substantially Equivalent on September 6, 1995, 50 days after the submission was received.
What is the product code of K953370?
The FDA product code is EQJ – Bur, Ear, Nose And Throat, a Class I (low risk) device regulated under 21 CFR 874.4140.