KARL STORZ Laryngoscopes and Accessories
FDA 510(k) clearance K252624 · decided 2026-05-15
Clearance details
- K-number
- K252624
- Device name
- KARL STORZ Laryngoscopes and Accessories
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-08-18
- Decision date
- 2026-05-15
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- EQN
- Device class
- 2
- Regulation number
- 874.4760
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- El Segundo, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ORL Video NasoPharyngo-Larngoscope (K150248) | Jedmed Instrument Company | 2015-07-23 |
| ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM (K132039) | Jedmed Instrument Co. | 2014-02-21 |
| OP-CON SURG. INSTRUMENT #7 (K834172) | Imm Enterprises , Ltd. | 1984-03-06 |
| LARYNGOSCOPE ATTACHMENT PH2000 (K831255) | Eder Instrument Co, Inc. | 1983-09-12 |
| COOL-LITE FIBERCOPTIC LARYNGEAL EXAM (K830888) | National Medical Technology | 1983-04-27 |
| LARYNGOSCOPES RIGID (K822525) | Kelleher Corp. | 1982-09-09 |
| NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT (K821707) | Kelleher Corp. | 1982-06-25 |
| NAGASHIMA LIGHT SOURCE UNIT SL-4 (K821708) | Kelleher Corp. | 1982-06-25 |
| NAGASHIMA LIGHT SOURCE UNIT SL-5 (K821709) | Kelleher Corp. | 1982-06-25 |
| NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL (K821706) | Kelleher Corp. | 1982-06-25 |
| NAGASHIMA NX-150F LIGHT SOURCE UNIT (K821710) | Kelleher Corp. | 1982-06-25 |
| TRACHEOSTOMY CARE TRAYS (K821269) | Intermed, Inc. | 1982-05-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Photodynamic Diagnostic D-Light C System (P050027/S034) | KARL STORZ Endoscopy-America, Inc. | 2025-10-01 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S033) | KARL STORZ Endoscopy-America, Inc. | 2025-05-02 |
| KARL STORZ Photodynamic Diagnostic D-Light C (PDD) System (P050027/S032) | KARL STORZ Endoscopy-America, Inc. | 2024-09-27 |
| KARL STORZ D-Light C PDD System (P050027/S031) | KARL STORZ Endoscopy-America, Inc. | 2023-05-05 |
| KARL STORZ D-Light C PDD System (P050027/S030) | KARL STORZ Endoscopy-America, Inc. | 2022-03-17 |
| KARL STORZ D-Light C PDD System (P050027/S028) | KARL STORZ Endoscopy-America, Inc. | 2022-02-04 |
| KARL STORZ D-Light C PDD System (P050027/S029) | KARL STORZ Endoscopy-America, Inc. | 2021-10-13 |
| D-Light C PDD System (P050027/S027) | KARL STORZ Endoscopy-America, Inc. | 2021-01-08 |