extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister
K143362 is the FDA 510(k) clearance record for extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister, a class II device, cleared for Devon Medical Products on under FDA product code OMP (Negative Pressure Wound Therapy Powered Suction Pump). FDA's definition for product code OMP reads: "For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of...". FDA records list 6 510(k) clearances for Devon Medical Products, from to . As of , FDA records show no recalls naming K143362.
Clearance record
- Decision date
- Received
- (71 days to decision)
- Product code
- OMP Negative Pressure Wound Therapy Powered Suction Pump
- Regulation
- 21 CFR 878.4780
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Applicant
- Devon Medical Products 1100 First Ave., Suite 202, King Of Prussia PA
- 510(k) summary
- Statement
- Third party review
- No
Clearances, product code OMP
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 1 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 1 |
| April 2026 | 0 |
| May 2026 | 3 |
| June 2026 | 2 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 1 |
| October 2026 | 0 |
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