3M Tegagen Hi Alginate Dressing & 3 M Tegagen HG Alginate Dressing, Model #'S 90110,90112,90114,90120, 90210,90212,90214
FDA 510(k) K982638 · Innovative Technologies , Ltd.
510(k) numberK982638
Submission
- Device name
- 3M Tegagen Hi Alginate Dressing & 3 M Tegagen HG Alginate Dressing, Model #'S 90110,90112,90114,90120, 90210,90212,90214
- Applicant
- Innovative Technologies , Ltd.
Winsford, Cheshire, GB - Received
- July 29, 1998
- Decision date
- August 21, 1998
- 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.
Other 510(k)s with product code QSY
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|---|---|---|---|
| K253017 | BloodSTOP iX Trauma Matrix (TM-iX-20)QSY · Traditional | Lifescience Plus, Inc. | 04/30/2026SE |
| K251700 | Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm…QSY · Traditional | Speciality Fibres and Materials Limited | 02/26/2026SE |
| K250319 | Mfuse (MS001)QSY · Traditional | Machina Medical, Inc. | 12/15/2025SE |
| K253609 | TRAUMAGEL® 2.0 Hemostatic GelQSY · Special | Cresilon, Inc. | 12/12/2025SE |
| 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 |
More from Medtrade Products , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K983303 | Innovative Technologies Hydrocolloid and Intelligent Hydrocolloid Wound DressingsMGP · Traditional | 12/09/1998SE |
| K982234 | Al-Gen Calcium Alginate DressingKMF · Traditional | 09/08/1998SE |
| K981753 | Innovative Technologies Transparent Film and Intelligent Film Wound DressingMGP · Traditional | 06/30/1998SE |
| K980989 | 3M Tegagen Hi Alginate Dressing & 3M Tegagen HG Alginate DressingKMF · Traditional | 05/27/1998SE |
| K980097 | Flexigel-G Hydrogel Wound DressingMGQ · Traditional | 03/04/1998SE |
| K973855 | It Hydrocolloid with ZincFRO · Traditional | 12/01/1997SN |
| K973312 | Transparent Film Dressing, Intelligent Film DressingMGP · Traditional | 10/22/1997SE |
| K973283 | Alginate/Zinc Wound DressingKMF · Traditional | 10/21/1997SN |
| K971126 | Hydrocolloid Wound DressingsFRO · Traditional | 06/24/1997SE |
| K963598 | Innovative Technologies Aliginate/Pectin Wound DressingsKMF · Traditional | 11/27/1996SE |
Questions and answers
When was 3M Tegagen Hi Alginate Dressing & 3 M Tegagen HG Alginate Dressing, Model #'S 90110,90112,90114,90120, 90210,90212,90214 cleared by the FDA?
3M Tegagen Hi Alginate Dressing & 3 M Tegagen HG Alginate Dressing, Model #'S 90110,90112,90114,90120, 90210,90212,90214 (K982638) received a 510(k) decision of Substantially Equivalent on August 21, 1998, 23 days after the submission was received.
What is the product code of K982638?
The FDA product code is QSY – Hemostatic Wound Dressing Without Thrombin Or Other Biologics, a Unclassified device.