KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES
FDA 510(k) clearance K950433 · decided 1995-03-15
Clearance details
- K-number
- K950433
- Device name
- KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES
- Applicant
- KARL STORZ Endoscopy-America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-02-02
- Decision date
- 1995-03-15
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- FGA
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- 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 |
|---|---|---|
| Percutaneous Nephroscope System (K232370) | Karl Storz SE & CO. KG | 2024-05-01 |
| Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set (K151308) | Schoelly Fiberoptic GmbH | 2016-02-09 |
| GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM (K072594) | Gyrus Acmi, Inc. | 2007-12-13 |
| NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20 (K994223) | Richard Wolf Medical Instruments Corp. | 2000-06-05 |
| KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE (K940594) | KARL STORZ Endoscopy-America, Inc. | 1994-09-09 |
| FLEXIBLE FIBER OPTIC ENDOSCOPE (K922826) | Optimed Technologies, Inc. | 1993-02-19 |
| OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE (K853486) | Olympus Corp. | 1985-09-12 |
| ACMI RIGI-FLEX NEPHORSCOPE (K791182) | American Cystocope Makers, Inc. | 1979-07-30 |
| PYELOSCOPE SYSTEM (K770729) | Richard Wolf Medical Instruments Corp. | 1977-04-28 |
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 |