Identity
- Trade Name
- Endoch FDA UDI
- Generic Name
- Rigid endoscopic scissors, single-use FDA UDI
- Device Name
- DISPOSABLE LAPAROSCOPIC MICRO SCISSORS, CURVED FDA UDI
- Model / Reference
- EAI-0818 FDA UDI
- Description
- DISPOSABLE LAPAROSCOPIC MICRO SCISSORS, CURVED FDA UDI
Identifiers
- Catalog Number
- EAI-0818 FDA UDI
- Primary DI / UDI-DI
- EAI0818 FDA UDI
- 510(k) Number
- K171825 FDA UDI
- FDA Product Code
- GEI FDA UDIJOK FDA UDI
- GMDN Term
- Rigid endoscopic scissors, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI880.6820 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rigid endoscopic scissors, single-use
Endoch by Endoch Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscopic scissors, single-use.
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- HERizon Disposable Endoscopic Scissors — MINERVA SURGICAL, INC. · Class I
- ELMED — ELMED INCORPORATED · Class II
- ELMED — ELMED INCORPORATED · Class II
- OMNI — Hologic, Inc. · Class I
- Single-Use Endoscopic Scissors — Guangzhou Red Pine Medical Instrument Co., Ltd. · Class I
- MEDLINE RENEWAL — MEDLINE INDUSTRIES, INC. · Class I
Cleared under the same submission
K171825 also covers:
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
- Endoch Inc
Sources (1)
- FDA UDI 3eb29f25-53ff-41d8-b42e-0dae866d2dbe 35 fields · synced Jun 6, 2026