Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Intraocular pressure-reducing compression system FDA UDI
- Device Name
- Honan balloon intraocular pressure reducer, relief valve, reusable bellows, headband, and case FDA UDI
- Model / Reference
- 6215E FDA UDI
- Description
- Honan balloon intraocular pressure reducer, relief valve, reusable bellows, headband, and case FDA UDI
Identifiers
- Catalog Number
- 6215E FDA UDI
- Primary DI / UDI-DI
- 00190660083120 FDA UDI
- 510(k) Number
- K820526 FDA UDI
- FDA Product Code
- LCC FDA UDI
- GMDN Term
- Intraocular pressure-reducing compression system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4610 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
Yes
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Intraocular pressure-reducing compression system
Ambler Surgical by Ambler Surgical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraocular pressure-reducing compression system.
- Honan Intraocular Pressure Reducer — LEBANON CORP, THE · Class II
- Honan Intraocular Pressure Reducer — LEBANON CORP, THE · Class II
- JEDMED — JEDMED Instrument Company · Class II
- Honan Intraocular Pressure Reducer — LEBANON CORP, THE · Class II
- Honan Intraocular Pressure Reducer — LEBANON CORP, THE · Class II
- HONAN BALLOON HEADBAND (NO LATEX) — Katena Products, Inc. · Class II
- Honan Intraocular Pressure Reducer — LEBANON CORP, THE · Class II
- Honan Intraocular Pressure Reducer — LEBANON CORP, THE · Class II
Cleared under the same submission
K820526 also covers:
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
- Ambler Surgical — Ambler Surgical, LLC
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
- Ambler Surgical, LLC
Sources (1)
- FDA UDI 285f1266-8e75-4c11-9f6b-94d63c58e77c 36 fields · synced Jun 1, 2026