MIKRO-AQUAPURATOR
FDA 510(k) clearance K895756 · decided 1989-12-27
Clearance details
- K-number
- K895756
- Device name
- MIKRO-AQUAPURATOR
- Applicant
- Mikro-Tek Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1989-09-26
- Decision date
- 1989-12-27
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- GBX
- Device class
- 1
- Regulation number
- 878.4200
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Bloomington, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mikro-Tek Laboratories
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 |
|---|---|---|
| MOERAE VEIN PREPARATION KIT (K131659) | Moerae Matrix, Inc. | 2014-03-03 |
| GRAFTGUARD PRESSURE CONTROLLING SYRINGE (K082725) | Maquet Cardiovascular, LLC | 2008-12-17 |
| DEUTSCH ANTI-BLOCKAGE WOUND DRAIN (K052286) | The Catheter Exchange, Inc. | 2005-10-21 |
| GRAFTSAVER (K043515) | Vescare, Inc. | 2005-03-31 |
| MISONIX IRRIGATION SYSTEM MOEDL BC20P (K013417) | Misonix, Inc. | 2002-01-10 |
| DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS) (K000704) | Dmc Medical, Ltd. | 2000-05-19 |
| LYSONIX IRRIGATION SYSTEM (K974233) | Lysonix, Inc. | 1998-02-03 |
| JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN (K973703) | Allegiance Healthcare Corp. | 1997-12-04 |
| ULTRACELL SUCTION SPONGE (K972635) | Ultracell Medical Technologies, Inc. | 1997-10-01 |
| FLAT CLOSED WOUND DRAIN WITH TROCAR (K965146) | Axiom Medical, Inc. | 1997-03-10 |
| SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR (K961295) | Sil-Med Corp. | 1996-06-26 |
| CLOSED FLUID COLLECTION SYSTEM (K961147) | B.Braun Medical, Inc. | 1996-05-31 |
Recalls involving this device
No recalls on record reference this clearance.