Perclot Topical
FDA 510(k) K132105 · Cryolife, Inc.
510(k) numberK132105
Submission
- Device name
- Perclot Topical
- Applicant
- Cryolife, Inc.
Kennesaw, GA, US - Received
- July 8, 2013
- Decision date
- April 3, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QSY – Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- Device class
- Unclassified
To temporarily control bleeding and cover external wounds.
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| K250319 | Mfuse (MS001)QSY · Traditional | Machina Medical, Inc. | 12/15/2025SE |
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| K240713 | Traumagel®QSY · Traditional | Cresilon, Inc. | 08/14/2024SE |
| K240097 | Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)QSY · Traditional | Ushare Medical, Inc. | 05/22/2024SE |
| K232216 | Hemoblock_S (Prescription); Hemoblock_S (OTC)QSY · Traditional | Incore Co., Ltd. | 04/19/2024SE |
| K240454 | RESPONDER® Polysaccharide HemostatQSY · Special | Starch Medical, Inc. | 03/15/2024SE |
| K220525 | RESPONDER Polysaccharide HemostatQSY · Traditional | Starch Medical, Inc. | 12/04/2023SE |
| K230589 | Celox Rapid X-Ray GauzeQSY · Traditional | Medtrade Products , Ltd. | 11/17/2023SE |
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Questions and answers
When was Perclot Topical cleared by the FDA?
Perclot Topical (K132105) received a 510(k) decision of Substantially Equivalent on April 3, 2014, 269 days after the submission was received.
What is the product code of K132105?
The FDA product code is QSY – Hemostatic Wound Dressing Without Thrombin Or Other Biologics, a Unclassified device.