Sterile Sphincterotome
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Sterile Sphincterotome FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- Sphincterotome EUDAMEDSterile Sphincterotome, lumen 3, TIP length 5, cutting wire 30, Outside diameter 2.5mm, Taper tip, no Rotation, half Insulation, preload guidewire, Single Cutting wire FDA UDI
- Model / Reference
- DSP-30530-111221 EUDAMEDFDA UDI
- Description
- Sterile Sphincterotome, lumen 3, TIP length 5, cutting wire 30, Outside diameter 2.5mm, Taper tip, no Rotation, half Insulation, preload guidewire, Single Cutting wire FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06902284507142 EUDAMED06932503513142 FDA UDI
- Basic UDI-DI
- 6902284SP58039P4 EUDAMED
- 510(k) Number
- K210934 FDA UDI
- FDA Product Code
- KNS FDA UDI
- EMDN Code
- G03040202 PAPILLOTOMES / SPHINCTEROTOMES, TRIPLE (OR MORE) LUMEN EUDAMED
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.4300 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Atherectomy Device Tip Length — 5 Millimeter FDA UDIAtherectomy Cutter Length — 30 Millimeter FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Sterile Sphincterotome by Micro-Tech (Nanjing) Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical handpiece/electrode, monopolar, single-use.
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- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
- CHOLE KIT 9 — APPLIED MEDICAL RESOURCES CORP. · Class II
Cleared under the same submission
K210934 also covers:
- Sphincterotome short-wire compatible — Micro-Tech (Nanjing) Co., Ltd.
- Sphincterotome short-wire compatible — Micro-Tech (Nanjing) Co., Ltd.
- Sphincterotome short-wire compatible — Micro-Tech (Nanjing) Co., Ltd.
- Sphincterotome short-wire compatible — Micro-Tech (Nanjing) Co., Ltd.
- Sphincterotome short-wire compatible — Micro-Tech (Nanjing) Co., Ltd.
- Sphincterotome short-wire compatible — Micro-Tech (Nanjing) Co., Ltd.
- Sphincterotome short-wire compatible — Micro-Tech (Nanjing) Co., Ltd.
- Sphincterotome short-wire compatible — Micro-Tech (Nanjing) Co., Ltd.
- Sphincterotome short-wire compatible — Micro-Tech (Nanjing) Co., Ltd.
- Sphincterotome short-wire compatible — Micro-Tech (Nanjing) Co., Ltd.
- Sphincterotome short-wire compatible — Micro-Tech (Nanjing) Co., Ltd.
- Sphincterotome short-wire compatible — Micro-Tech (Nanjing) Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Micro-Tech (Nanjing) Co., Ltd.
Sources (2)
- FDA UDI c23afda5-7f70-4d06-b6b4-80e571403863 36 fields · synced Oct 8, 2026
- EUDAMED 6ed9ffaf-81a8-4b0a-b3e3-10f192201b38 61 fields · synced Oct 8, 2026