Karl Storz UROMAT E.A.S.I.
FDA 510(k) clearance K162992 · decided 2017-07-07
Clearance details
- K-number
- K162992
- Device name
- Karl Storz UROMAT E.A.S.I.
- Applicant
- Karl Storz Endoscopy America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-10-27
- Decision date
- 2017-07-07
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- LJH
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- El Segundo, CA, US
- Third-party review
- No
- Expedited review
- No
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| AMSURE BLADDER IRRIGATION SET (K070873) | Amsino Intl., Inc. | 2007-12-19 |
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| SPYGLASS IRRIGATION SYSTEM (K063700) | Medical Scientific, Inc. | 2007-02-08 |
| NEXUS IRRIGATION TUBING SET (K062551) | Nexus Medical, LLC | 2006-12-15 |
| URO PRO (K042457) | W.O.M. World of Medicine AG | 2004-10-25 |
| PIGGYBACK IRRIGATING SYSTEM (K040094) | Kosin Technologies, LLC | 2004-04-15 |
| IRRIGATION SETS (K023808) | International Medsurg Connection | 2003-03-10 |
| MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 (K010607) | Benlan, Inc. | 2001-11-28 |
| CONTINUOUS FLOW Y-TUBING (K010122) | G.U.-Tek | 2001-06-04 |
| FLO ASSISTANT, MODEL 4-250-00 (K001325) | Northgate Technologies, Inc. | 2000-08-18 |
| MTP UROPUMP DISPOSABLE TUBING SET (K990909) | Mtp Medical Technical Promotion GmbH | 1999-06-09 |
| KSEA UROPUMP (K981615) | KARL STORZ Endoscopy-America, Inc. | 1998-07-08 |
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 |