Identity
- Trade Name
- Quest Laparoscope FDA UDI
- Generic Name
- Rigid optical laparoscope FDA UDI
- Model / Reference
- ART-LAP-0007 FDA UDI
Identifiers
- Catalog Number
- ART-LAP-0007 FDA UDI
- Primary DI / UDI-DI
- 08719324487023 FDA UDI
- 510(k) Number
- K945266 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Rigid optical laparoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid optical laparoscopeRigid video laparoscope
Quest Laparoscope by Quest Projects B.V. — 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
K945266 also covers:
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Biopsy forceps — SOPRO-COMEG GmbH
- Biopsy forceps — SOPRO-COMEG GmbH
- Biopsy forceps — SOPRO-COMEG GmbH
- Biopsy forceps — SOPRO-COMEG GmbH
- Dilation set — SOPRO-COMEG GmbH
- Electrode — SOPRO-COMEG GmbH
- Grasping forceps — SOPRO-COMEG GmbH
- Grasping forceps — SOPRO-COMEG GmbH
- Grasping forceps — SOPRO-COMEG GmbH
- Grasping forceps — SOPRO-COMEG GmbH
- Grasping forceps — SOPRO-COMEG GmbH
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
- Quest Projects B.V.
Sources (1)
- FDA UDI 74617c1c-1c00-4c74-8f2f-006409a7f918 34 fields · synced Jun 8, 2026