KARL STORZ Laryngoscopes and Accessories
FDA 510(k) K252624 · KARL STORZ Endoscopy-America, Inc.
510(k) numberK252624
Submission
- Device name
- KARL STORZ Laryngoscopes and Accessories
- Applicant
- KARL STORZ Endoscopy-America, Inc.
El Segundo, CA, US - Received
- August 18, 2025
- Decision date
- May 15, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EQN – Laryngoscope, Nasopharyngoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4760
- Specialty
- Ear, Nose, Throat
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code EQN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150248 | ORL Video NasoPharyngo-LarngoscopeEQN · Traditional | Jedmed Instrument Company | 07/23/2015SE |
| K132039 | Ergo-Flex Laryngo-Nasopharyngoscope Ef-N and Ef-N SlimEQN · Traditional | Jedmed Instrument Co. | 02/21/2014SE |
| K834172 | Op-Con Surg. Instrument #7EQN · Traditional | Imm Enterprises , Ltd. | 03/06/1984SE |
| K831255 | Laryngoscope Attachment PH2000EQN · Traditional | Eder Instrument Co, Inc. | 09/12/1983SE |
| K830888 | Cool-Lite Fibercoptic Laryngeal ExamEQN · Traditional | National Medical Technology | 04/27/1983SE |
| K822525 | Laryngoscopes RigidEQN · Traditional | Kelleher Corp. | 09/09/1982SE |
| K821710 | Nagashima NX-150F Light Source UnitEQN · Traditional | Kelleher Corp. | 06/25/1982SE |
| K821709 | Nagashima Light Source Unit SL-5EQN · Traditional | Kelleher Corp. | 06/25/1982SE |
| K821708 | Nagashima Light Source Unit SL-4EQN · Traditional | Kelleher Corp. | 06/25/1982SE |
| K821707 | Nagashima Sft-Ii Laryngoscope StraightEQN · Traditional | Kelleher Corp. | 06/25/1982SE |
More from Kelleher Corp.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K221174 | Telepack +FET · Special | 05/13/2022SE |
Questions and answers
When was KARL STORZ Laryngoscopes and Accessories cleared by the FDA?
KARL STORZ Laryngoscopes and Accessories (K252624) received a 510(k) decision of Substantially Equivalent on May 15, 2026, 270 days after the submission was received.
What is the product code of K252624?
The FDA product code is EQN – Laryngoscope, Nasopharyngoscope, a Class II (moderate risk) device regulated under 21 CFR 874.4760.