Identity
- Trade Name
- SurroundScope Endoscope FDA UDI
- Generic Name
- Rigid video laparoscope FDA UDI
- Device Name
- SurroundScope Endoscope 90 deg FDA UDI
- Model / Reference
- SurroundScope Endoscope FDA UDI
- Description
- SurroundScope Endoscope 90 deg FDA UDI
Identifiers
- Catalog Number
- 300004 FDA UDI
- Primary DI / UDI-DI
- 07290116580005 FDA UDI
- 510(k) Number
- K210104 FDA UDI
- FDA Product Code
- HET FDA UDI
- GMDN Term
- Rigid video laparoscope 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid video laparoscope
SurroundScope Endoscope by 270surgical , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Rigid video laparoscope.
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- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
Cleared under the same submission
K210104 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 |
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Manufacturer
- Manufacturer
- 270surgical , Ltd.
Sources (1)
- FDA UDI 4ed67d15-dc6d-4a3a-b592-e33a5a990135 36 fields · synced Jun 6, 2026