Identity
- Trade Name
- LEEP PRECISION™ Smoke Evacuation System FDA UDI
- Generic Name
- Surgical plume evacuation system FDA UDI
- Device Name
- LEEP PRECISION™ Smoke Evacuation System (120 VAC) FDA UDI
- Model / Reference
- DM53502 FDA UDI
- Description
- LEEP PRECISION™ Smoke Evacuation System (120 VAC) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937019940 FDA UDI
- 510(k) Number
- K910377 FDA UDI
- FDA Product Code
- GCX FDA UDI
- GMDN Term
- Surgical plume evacuation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6740 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical plume evacuation system
LEEP PRECISION™ Smoke Evacuation System by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K910377 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA UDI a158ad6d-7ef4-492a-aebb-b60e4b6936fe 34 fields · synced Jun 9, 2026