Identity
- Trade Name
- Sphincterotome short-wire compatible FDA UDI
- Generic Name
- Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
- Device Name
- Sphincterotome / short-wire compatible, lumen 3, TIP length 5mm, cutting wire 25mm, Outside diameter 2.5mm, Cone, no half Insulation, no preload guidewire, Single Cutting wire FDA UDI
- Model / Reference
- RDSP-0525-111 FDA UDI
- Description
- Sphincterotome / short-wire compatible, lumen 3, TIP length 5mm, cutting wire 25mm, Outside diameter 2.5mm, Cone, no half Insulation, no preload guidewire, Single Cutting wire FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06932503575072 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
Sphincterotome short-wire compatible 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.
- GeniSurge — Genicon · Class II
- BE-ST ElectroCautery Pencil — LACEY MANUFACTURING COMPANY LLC · Class II
- Arthrex® — Arthrex, Inc. · Class II
- Short Throw — US Endoscopy · Class II
- Single Use Electrosurgical Knife KD-655 — Olympus Medical Systems Corporation · Class II
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micro-Tech (Nanjing) Co., Ltd.
Sources (1)
- FDA UDI 2ff8abb0-51cd-460b-85db-f0ae7f723317 36 fields · synced Jun 6, 2026