Identity
- Trade Name
- SMTP FDA UDI
- Generic Name
- Hard/soft-tissue ultrasonic surgical system FDA UDI
- Device Name
- Bilateral scalpel with serrations (8cm) FDA UDI
- Model / Reference
- XDF02801521 FDA UDI
- Description
- Bilateral scalpel with serrations (8cm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972603518791 FDA UDI
- 510(k) Number
- K212750 FDA UDI
- FDA Product Code
- LFL FDA UDI
- GMDN Term
- Hard/soft-tissue ultrasonic surgical system FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Hard/soft-tissue ultrasonic surgical system
Smtp by SMTP Medical Co., Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hard/soft-tissue ultrasonic surgical system.
- OSCAR 3 — Orthofix, Inc. · Class II
- ACTEON — Satelec · Class II
- TORS — RADLEY SCIENTIFIC LIMITED · Class II
- ACTEON — Satelec · Class II
- OSCAR 3 — Orthofix, Inc. · Class II
- ACTEON — Satelec · Class II
- Axiom Blades — Peter Brasseler Holdings, LLC · Class II
- Piezomed Pro Accessory — W & H Dentalwerk Bürmoos GmbH · Class II
Cleared under the same submission
K212750 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 U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SMTP Medical Co., Ltd.
Sources (1)
- FDA UDI 20f07bff-d31b-44d7-a012-a3e999002b6f 34 fields · synced May 30, 2026