GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
FDA 510(k) clearance K072594 · decided 2007-12-13
Clearance details
- K-number
- K072594
- Device name
- GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM
- Applicant
- Gyrus Acmi, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-09-14
- Decision date
- 2007-12-13
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- FGA
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Southborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| 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 |
| 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Spiration® Valve System (P180007/S013) | Gyrus Acmi, Inc. | 2024-08-16 |
| Spiration Valve System Deployment Catheter and Loader (P180007/S012) | Gyrus Acmi, Inc. | 2024-06-27 |
| Spiration Valve System (P180007/S011) | Gyrus Acmi, Inc. | 2023-09-22 |
| SVS Deployment Catheter and Loader (P180007/S009) | Gyrus Acmi, Inc. | 2022-05-12 |
| Spiration Valve System (P180007/S008) | Gyrus Acmi, Inc. | 2021-09-01 |
| Falope Ring Band and Applicator Systems (P870076/S027) | Gyrus Acmi, Inc. | 2021-05-19 |
| Falope-Ring® Band and Applicator Systems (P870076/S026) | Gyrus Acmi, Inc. | 2021-05-11 |
| Spiration® Valve System (SVS) (P180007/S007) | Gyrus Acmi, Inc. | 2020-12-23 |