KARL STORZ ENT SHAVER
FDA 510(k) clearance K953370 · decided 1995-09-06
Clearance details
- K-number
- K953370
- Device name
- KARL STORZ ENT SHAVER
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-07-18
- Decision date
- 1995-09-06
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- EQJ
- Device class
- 1
- Regulation number
- 874.4140
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Culver City, 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 |
|---|---|---|
| Precision Thin Reciprocating Blade, 0.010in. (K161514) | Stryker Corporation | 2017-01-17 |
| XPS CURVED BUR (K041985) | Medtronic Xomed, Inc. | 2004-08-12 |
| ESSENTIAL SHAVER SYSTEM (K974232) | Gyrus Ent LLC | 1998-01-12 |
| ACE SYSTEM (K960853) | Xomed, Inc. | 1996-04-03 |
| TREBAY MICRODEBRIDER SYSTEM (K955704) | Trebay Medical Corp. | 1996-01-30 |
| SOF - ABRASION BUR (K955294) | Trebay Medical Corp. | 1995-12-22 |
| TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) (K954912) | Trebay Medical Corp. | 1995-12-06 |
| KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL (K950337) | KARL STORZ Endoscopy-America, Inc. | 1995-08-23 |
| REDI DRILL DRILL SYSTEM (K952609) | Trebay Medical Corp. | 1995-07-31 |
| ESSENTIAL SHAVER SYSTEM (K953096) | Smith & Nephew Richards, Inc. | 1995-07-28 |
| KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION (K946332) | KARL STORZ Endoscopy-America, Inc. | 1995-06-05 |
| TREBAY IRRGATED CUTTER BLADE (K951526) | Trebay Medical Corp. | 1995-05-12 |
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 |