Identity
- Trade Name
- DISPOSABLE HANDSWITCH SUCTION COAGULATOR FDA UDI
- Generic Name
- Surgical power tool hand-switch FDA UDI
- Device Name
- DISPOSABLE HAND SWITCH SUCTION COAGULATOR WITH CABLE FDA UDI
- Model / Reference
- SCH10 FDA UDI
- Description
- DISPOSABLE HAND SWITCH SUCTION COAGULATOR WITH CABLE FDA UDI
Identifiers
- Catalog Number
- SCH10 FDA UDI
- Primary DI / UDI-DI
- 00192896009462 FDA UDI
- 510(k) Number
- K033003 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Surgical power tool hand-switch 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 3 Meter FDA UDI
Category: Surgical power tool hand-switch
Disposable Handswitch Suction Coagulator by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical power tool hand-switch.
- STRYKER — Stryker Corp. · Class II
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- CORE — Stryker Corp. · Class II
- MIDAS REX MR8 — Medtronic Powered Surgical Solutions · Class II
- Midas Rex MR8 — Medtronic PS Medical · Class II
- CORE, Sumex — Stryker Corp. · Class II
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
- De Soutter Medical — De Soutter Medical, Ltd. · Class I
Cleared under the same submission
K033003 also covers:
- CONMED — Conmed Corporation
- Symmetry Olsen — Olsen Medical
- Symmetry Olsen — Olsen Medical
- DISPOSABLE FOOTSWITCH SUCTION COAGULATOR — SONTEC INSTRUMENTS, INC.
- DISPOSABLE FOOTSWITCH SUCTION COAGULATOR — SONTEC INSTRUMENTS, INC.
- DISPOSABLE HANDSWITCH SUCTION COAGULATOR — SONTEC INSTRUMENTS, INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
- Bovie — SYMMETRY SURGICAL INC.
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
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI ace0ac1a-ae60-4dcf-82a7-fef965a73c00 37 fields · synced May 30, 2026