Identity
- Trade Name
- HEMOSTATIX THERMAL SCALPEL SYSTEM FDA UDI
- Generic Name
- Haemostatic knife FDA UDI
- Device Name
- MODEL P8400 CONSOLE - QTY 1 FDA UDI
- Model / Reference
- 7013-8400 FDA UDI
- Description
- MODEL P8400 CONSOLE - QTY 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850007350208 FDA UDI
- 510(k) Number
- K091107 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Haemostatic knife FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
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
Yes
FDA UDI
Category: Haemostatic knife
Hemostatix Thermal Scalpel System by C2dx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemostatic knife.
- HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 FOOTSWITCH — HEMOSTATIX MEDICAL TECHNOLOGIES LLC · Class II
- YASARGIL ARACHNOID KNIFE — SONTEC INSTRUMENTS, INC. · Class I
- TREPHINE — KLS-Martin L.P. · Class I
- HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5812 BLADE — HEMOSTATIX MEDICAL TECHNOLOGIES LLC · Class II
- HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5715 BLADE - QTY 24 — HEMOSTATIX MEDICAL TECHNOLOGIES LLC · Class II
- YASARGIL BAYONET ARACHNOID KNIFE — SONTEC INSTRUMENTS, INC. · Class I
- YASARGIL ARACHNOID KNIFE — SONTEC INSTRUMENTS, INC. · Class I
- HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 5710 BLADE - QTY 24 — HEMOSTATIX MEDICAL TECHNOLOGIES LLC · Class II
Cleared under the same submission
K091107 also covers:
- SHAW SCALPEL — C2DX, INC.
- SHAW SCALPEL — C2DX, INC.
- HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 8050 HANDLE - QTY 1 — HEMOSTATIX MEDICAL TECHNOLOGIES LLC
- HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL 8051 HANDLE - QTY 1 — HEMOSTATIX MEDICAL TECHNOLOGIES LLC
- HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 CONTROLLER — HEMOSTATIX MEDICAL TECHNOLOGIES LLC
- HEMOSTATIX THERMAL SCALPEL SYSTEM MODEL P8400 FOOTSWITCH — HEMOSTATIX MEDICAL TECHNOLOGIES LLC
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 |
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Manufacturer
- Manufacturer
- C2dx, Inc.
Sources (1)
- FDA UDI d864d965-1bd6-4fda-9600-5553724590fa 35 fields · synced Jun 8, 2026