Identity
- Trade Name
- LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter FDA UDI
- Generic Name
- Hand-held ultrasound imaging system, body-surface FDA UDI
- Device Name
- LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter FDA UDI
- Model / Reference
- 490-00183-02, 490-00189-02 FDA UDI
- Description
- LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00866646000305 FDA UDI
- 510(k) Number
- K163510 FDA UDI
- FDA Product Code
- ITX FDA UDIIYO FDA UDIIYN FDA UDI
- GMDN Term
- Hand-held ultrasound imaging system, body-surface FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1560 FDA UDI892.1550 FDA UDI
- Commercial Distribution
- Not 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
MR Unsafe FDA UDI
LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter by Butterfly Network, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K163510 also covers:
- BUTTERFLY iQ/iQ+ WIRELESS CHARGER KIT — Butterfly Network, Inc.
- LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.25 meter — Butterfly Network, Inc.
- LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter — Butterfly Network, Inc.
- LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.00 meter — Butterfly Network, Inc.
- LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.50 meter — Butterfly Network, Inc.
- USB-C CABLE ASSEMBLY, USB 2.0, 1.25 meter — Butterfly Network, Inc.
- USB-C CABLE ASSEMBLY, USB 2.0, 1.50 meter — Butterfly Network, Inc.
- USB-C CABLE ASSEMBLY, USB 2.0, 2.00 meter — Butterfly Network, Inc.
- USB-C CABLE ASSEMBLY, USB 2.0, 2.50 meter — Butterfly Network, Inc.
- USB-C CABLE ASSEMBLY, USB 3.1 GEN 1, 1.50 meter — Butterfly Network, 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
- Butterfly Network, Inc.
Sources (1)
- FDA UDI 04062d4f-97b4-4491-b2c8-0ab9398fd33e 36 fields · synced Jun 9, 2026