TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS
FDA 510(k) clearance K960787 · decided 1996-05-14
Clearance details
- K-number
- K960787
- Device name
- TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1996-02-26
- Decision date
- 1996-05-14
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- LJH
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Round Lake, IL, 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 |
|---|---|---|
| Karl Storz UROMAT E.A.S.I. (K162992) | Karl Storz Endoscopy America, Inc. | 2017-07-07 |
| AMSURE BLADDER IRRIGATION SET (K070873) | Amsino Intl., Inc. | 2007-12-19 |
| MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM (K071832) | Medical Scientific, Inc. | 2007-09-18 |
| 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 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Container recall (Z-1010-2015) | Baxter Healthcare Corp. | 2015-01-26 |
| Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C401 recall (Z-1682-2013) | Baxter Healthcare Corp. | 2013-07-10 |
| Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product recall (Z-1683-2013) | Baxter Healthcare Corp. | 2013-07-10 |
| Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Produc recall (Z-1684-2013) | Baxter Healthcare Corp. | 2013-07-10 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077) | Baxter Healthcare Corp | 2025-11-13 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076) | Baxter Healthcare Corp | 2025-06-30 |
| Floseal Hemostatic Matrix (P990009/S075) | Baxter Healthcare Corp | 2025-01-30 |
| Adept Adhesion Reduction Solution (P050011/S009) | Baxter Healthcare Corp | 2024-08-23 |
| Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074) | Baxter Healthcare Corp | 2024-08-15 |
| Floseal Hemostatic Matrix (P990009/S073) | Baxter Healthcare Corp | 2024-01-10 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072) | Baxter Healthcare Corp | 2023-12-12 |
| Floseal Hemostatic Matrix, RT5 (P990009/S070) | Baxter Healthcare Corp | 2023-02-02 |