Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
FDA 510(k) clearance K151308 · decided 2016-02-09
Clearance details
- K-number
- K151308
- Device name
- Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
- Applicant
- Schoelly Fiberoptic GmbH
- Decision
- Substantially Equivalent
- Date received
- 2015-05-18
- Decision date
- 2016-02-09
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- FGA
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Denzlingen, DE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Schoelly Fiberoptic GmbH
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| 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 ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES (K950433) | KARL STORZ Endoscopy-America, Inc. | 1995-03-15 |
| 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.