Identity
- Trade Name
- ACU-NEEDLE FDA UDI
- Generic Name
- Body aspiration needle, single-use FDA UDI
- Device Name
- 22 standard gauge 2 3/4" Liposuction/injection needle, metal hub, 3", for suction and injection of fat, blunt or tri-beveled, non-sterile FDA UDI
- Model / Reference
- N2235 FDA UDI
- Description
- 22 standard gauge 2 3/4" Liposuction/injection needle, metal hub, 3", for suction and injection of fat, blunt or tri-beveled, non-sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10814105020385 FDA UDI
- 510(k) Number
- K874024 FDA UDI
- FDA Product Code
- FMI FDA UDI
- GMDN Term
- Body aspiration needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5570 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
No
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: Body aspiration needle, single-use
Acu-Needle by Acuderm, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Body aspiration needle, single-use.
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- COMPLETE-CHIBA MR — STERYLAB SRL · Class II
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Cleared under the same submission
K874024 also covers:
- ACU-NEEDLE — ACUDERM, INC.
- ACU-NEEDLE — ACUDERM, INC.
- ACU-NEEDLE — ACUDERM, INC.
- ACU-NEEDLE — ACUDERM, INC.
- ACU-NEEDLE — ACUDERM, INC.
- ACU-NEEDLE — ACUDERM, INC.
- ACU-NEEDLE — ACUDERM, INC.
- ACU-NEEDLE — ACUDERM, INC.
- ACU-NEEDLE — ACUDERM, INC.
- ACU-NEEDLE — ACUDERM, INC.
- ACU-NEEDLE — ACUDERM, INC.
- ACU-NEEDLE — ACUDERM, 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
- Acuderm, Inc.
Sources (1)
- FDA UDI 031bb213-85b0-44ce-817e-5512452c22aa 35 fields · synced Jun 8, 2026