Identity
- Trade Name
- Suction Irrigation Handle FDA UDI
- Generic Name
- Endoscope suction valve, reusable FDA UDI
- Device Name
- Suction-Irrigation Handle 3-Way Tap Large Adapter Luer-Lock Male FDA UDI
- Model / Reference
- 26943-21 FDA UDI
- Description
- Suction-Irrigation Handle 3-Way Tap Large Adapter Luer-Lock Male FDA UDI
Identifiers
- Catalog Number
- 26943-21 FDA UDI
- Primary DI / UDI-DI
- 00192896111424 FDA UDI
- 510(k) Number
- K002877 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Endoscope suction valve, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Category: Endoscope suction valve, reusable
Suction Irrigation Handle by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope suction valve, reusable.
- EM — Allied Medical LLC · Class I
- Suction valve — Olympus Medical Systems Corporation · Class II
- DUFNER Instrumente GmbH — DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik · Class II
- DUFNER Instrumente GmbH — DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik · Class II
- SUCTION VALVE — Olympus Medical Systems Corporation · Class II
- SUCTION VALVE — Olympus Medical Systems Corporation · Class II
- FUJIFILM — FUJIFILM Corporation · Class I
- PENTAX — HOYA CORPORATION · Class II
Cleared under the same submission
K002877 also covers:
- DUFNER Instrumente GmbH — DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik
- DUFNER Instrumente GmbH — DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik
- DUFNER Instrumente GmbH — DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik
- DUFNER Instrumente GmbH — DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik
- DUFNER Instrumente GmbH — DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik
- DUFNER Instrumente GmbH — DUFNER - Instrumente GmbH Fabrik ärztlicher Instrumente Medizintechnik
- DOLPHIN GRASPING FORCEP INSERT — SONTEC INSTRUMENTS, INC.
- FLEXIBLE TROCAR SLEEVE — SONTEC INSTRUMENTS, INC.
- LOWER SEAL FOR MICTEC GLASS BOTTLE — SONTEC INSTRUMENTS, INC.
- MICASEPT ATRAUMATIC PARENCHYM CLAMP — SONTEC INSTRUMENTS, INC.
- MICASEPT BIOPSY AND GRASPING FORCEPS — SONTEC INSTRUMENTS, INC.
- MICASEPT CIRADUR METZENBAUM SCISSORS — SONTEC INSTRUMENTS, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI dbe2d174-5964-42f4-b6a9-48cb38d15b4a 36 fields · synced Jun 6, 2026