MicroDoc Mini Stingray and Drape Set 8463550 2003
MicroDoc Mini Stingray and Drape Set 8463550 2003 is a negative-pressure wound therapy tubing set (FDA Class II; FDA product code OMP, Negative Pressure Wound Therapy Powered Suction Pump) made by Pensar Medical, LLC, cleared under FDA 510(k) K200223 on 23 Oct 2020 and listed in FDA GUDID since 7 Oct 2022 (UDI-DI 00851978007146), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00851978007146 | Date7 Oct 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK200223 | Date23 Oct 2020 | StatusActive |
Official records
- AccessGUDID record 00851978007146
- FDA 510(k) database K200223
Across registries
- FDA 510(k) K200223 decided 23 Oct 2020 Active
- FDA GUDID UDI-DI 00851978007146 listed 7 Oct 2022 Listed
Timeline
- Cleared FDA 510(k) K200223
- Listed FDA GUDID 00851978007146
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MicroDoc Mini Stingray and Drape Set
- Generic name
- Negative-pressure wound therapy tubing set
- Model / reference
- 8463550 2003
- Primary DI / UDI-DI
- 00851978007146
- 510(k) Number
- FDA product code
- OMP
- GMDN term
- Negative-pressure wound therapy tubing set
- Device class
- Class II
- Regulation number
- 878.4780
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code OMP (Negative Pressure Wound Therapy Powered Suction Pump).
- Genadyne UNO Plus Negative Pressure Wound Therapy System by GENADYNE BIOTECHNOLOGIES INC.
- V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D by Kci USA, Inc. (Kinetic Concepts, Inc.)
- Genadyne Hybrid Foam Dressings by GENADYNE BIOTECHNOLOGIES INC.
- FloSure Ventilation Patch by Simex Medizintechnik GmbH
- V.A.C. DERMATAC Drape by KCI USA, INC.
- ANTLIA I WOUND IRRIGATION SYSTEM by Innovative Therapies, Inc.
- Avance Solo Negative Pressure Wound Therapy (NPWT) System by Molnlycke Health Care Us, LLC
- PICO Single Use Negative Pressure Wound Therapy System by Smith & Nephew Medical, Ltd.
- Whisper Pump System by Wound RX Medical, LLC
- PWD Negative Pressure Wound Therapy System by Applied Tissue Technologies, LLC