Identity
- Trade Name
- Sterile Sphincterotome FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- Sterile Sphincterotome, lumen 3, TIP length 5, cutting wire 25, Outside diameter 2.5mm, Taper tip, no Rotation, half Insulation, preload guidewire, Single Cutting wire FDA UDI
- Model / Reference
- DSP-30525-111221 FDA UDI
- Description
- Sterile Sphincterotome, lumen 3, TIP length 5, cutting wire 25, Outside diameter 2.5mm, Taper tip, no Rotation, half Insulation, preload guidewire, Single Cutting wire FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06932503513128 FDA UDI
- 510(k) Number
- K210934 FDA UDI
- FDA Product Code
- KNS FDA UDI
- GMDN Term
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4300 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
No
FDA UDI
Dimensions & Sizes
- Size
- Atherectomy Device Tip Length — 5 Millimeter FDA UDIAtherectomy Cutter Length — 25 Millimeter FDA UDI
Category: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Sterile Sphincterotome by Micro-Tech (Nanjing) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical handpiece/electrode, monopolar, single-use.
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- Polyp Pak — US Endoscopy · Class II
- 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 (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
- Micro-Tech (Nanjing) Co., Ltd.
Sources (1)
- FDA UDI 605e32b7-866a-4250-b1c2-622072233829 36 fields · synced May 30, 2026