MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES
FDA 510(k) clearance K061079 · decided 2006-06-02
Clearance details
- K-number
- K061079
- Device name
- MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES
- Applicant
- Medtrade Products , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2006-04-17
- Decision date
- 2006-06-02
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- QSY
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Crewe, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Medtrade Products
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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 |
|---|
| BloodSTOP iX Trauma Matrix (TM-iX-20) (K253017) | Lifescience Plus, Inc. | 2026-04-30 |
| Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm (K251700) | Speciality Fibres and Materials Limited | 2026-02-26 |
| MFUSE (MS001) (K250319) | Machina Medical, Inc. | 2025-12-15 |
| TRAUMAGEL® 2.0 Hemostatic Gel (K253609) | Cresilon, Inc. | 2025-12-12 |
| TRAUMAGEL® (K240713) | Cresilon, Inc. | 2024-08-14 |
| Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) (K240097) | Ushare Medical, Inc. | 2024-05-22 |
| Hemoblock_S (Prescription); Hemoblock_S (OTC) (K232216) | Incore Co., Ltd. | 2024-04-19 |
| RESPONDER® Polysaccharide Hemostat (K240454) | Starch Medical, Inc. | 2024-03-15 |
| RESPONDER Polysaccharide Hemostat (K220525) | Starch Medical, Inc. | 2023-12-04 |
| Celox Rapid X-Ray Gauze (K230589) | Medtrade Products , Ltd. | 2023-11-17 |
| Hemostatic Dressing (K213413) | Jiangsu Newvalue Medical Products Co., Ltd. | 2023-09-01 |
| Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) (K213652) | Cresilon, Inc. | 2023-06-28 |
Recalls involving this device
No recalls on record reference this clearance.