Identity
- Trade Name
- InstaClear FDA UDI
- Generic Name
- Flexible fibreoptic nasopharyngoscope FDA UDI
- Device Name
- SHEATH, LENS CLEANER ULTRA 70 DEGREES, TOP LIGHT INSTACLEAR (5/PK) FDA UDI
- Model / Reference
- LCS4K70TPOL FDA UDI
- Description
- SHEATH, LENS CLEANER ULTRA 70 DEGREES, TOP LIGHT INSTACLEAR (5/PK) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925041516 FDA UDI
- 510(k) Number
- K152531 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Flexible fibreoptic nasopharyngoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 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
Category: Flexible fibreoptic nasopharyngoscope
InstaClear by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible fibreoptic nasopharyngoscope.
- Nasopharyngoscope, Flexible — Ecleris · Class II
- ENTity SDXL Nasopharyngoscope — OPTIM LLC · Class II
- BR Surgical, LLC — BR SURGICAL LLC · Class II
- ENT 3.6FP30 Nasopharyngoscope — OPTIM LLC · Class II
- Nasopharyngoscope, Flexible — Ecleris · Class II
- MACHIDA — MACHIDA ENDOSCOPE CO., LTD. · Class II
- ENTity XL (PA Compatible) Nasopharyngoscope — OPTIM LLC · Class II
- Entity SDXL Plus Nasopharyngoscope — OPTIM LLC · Class II
Cleared under the same submission
K152531 also covers:
- InstaClear — Gyrus Acmi, Inc.
- InstaClear — Gyrus Acmi, Inc.
- InstaClear — Gyrus Acmi, Inc.
- InstaClear — Gyrus Acmi, Inc.
- InstaClear — Gyrus Acmi, Inc.
- InstaClear — Gyrus Acmi, Inc.
- InstaClear — Gyrus Acmi, Inc.
- InstaClear — Gyrus Acmi, Inc.
- InstaClear — Gyrus Acmi, Inc.
- InstaClear — Gyrus Acmi, Inc.
- InstaClear — Gyrus Acmi, Inc.
- InstaClear — Gyrus Acmi, Inc.
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
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 8cc38330-30af-4d77-a8d5-4db7334563c9 34 fields · synced May 30, 2026