Identity
- Trade Name
- Endoplus FDA UDI
- Generic Name
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
- Device Name
- 5mm Maxi Fenestrated Grasping Forcep, Ratcheting Handle FDA UDI
- Model / Reference
- E338R FDA UDI
- Description
- 5mm Maxi Fenestrated Grasping Forcep, Ratcheting Handle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817401024043 FDA UDI
- 510(k) Number
- K925079 FDA UDI
- FDA Product Code
- HET FDA UDI
- GMDN Term
- Rigid endoscopic tissue manipulation forceps, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1720 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
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid endoscopic tissue manipulation forceps, reusable
Endoplus by Endoplus — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid endoscopic tissue manipulation forceps, reusable.
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- HYSAFE — Richard Wolf GmbH · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Slide n Lock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Novo Surgical — NOVO SURGICAL, INC. · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Speedlock — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
Cleared under the same submission
K925079 also covers:
- 10mm Babcock Short Jaw, 35cm, Ratcheting Handle, With Rotation — ENCISION, INC.
- 5mm Atraumatic Grasper, Slide Lock Handle — ENCISION, INC.
- 5mm Debakey Tissue Forcep, Ratcheting Handle, With Rotation, 35cm — ENCISION, INC.
- 5mm Endo Babcock Forcep, Ratcheting Handle, With Rotation — ENCISION, INC.
- Curved Maryland Dissector, 23mm Jaw, Ratcheting Handle With Rotation, 45cm — ENCISION, INC.
- Endoplus — Endoplus
- Endoplus — Endoplus
- Endoplus — Endoplus
- Endoplus — Endoplus
- Endoplus — Endoplus
- Endoplus — Endoplus
- Endoplus — Endoplus
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
- Endoplus
Sources (1)
- FDA UDI 0c3e0eff-5221-42e2-9c6c-f9ebb8bcbc2b 34 fields · synced May 31, 2026