Identity
- Trade Name
- SofTIP FDA UDI
- Generic Name
- Suture cutter, single-use FDA UDI
- Device Name
- A sterile tube-like device intended to facilitate the use of an open-surgery ligature loop ligator by guiding and protecting its passage through other tissues. It is made of plastic materials. This is a single-use device. FDA UDI
- Model / Reference
- Long FDA UDI
- Description
- A sterile tube-like device intended to facilitate the use of an open-surgery ligature loop ligator by guiding and protecting its passage through other tissues. It is made of plastic materials. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- 6002 FDA UDI
- Primary DI / UDI-DI
- 00818354017601 FDA UDI
- 510(k) Number
- K090385 FDA UDI
- FDA Product Code
- GAT FDA UDI
- GMDN Term
- Suture cutter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5000 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: Suture cutter, single-use
SofTIP by Atricure, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suture cutter, single-use.
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- Sklar® — Sklar Corporation · Class I
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- NovoCut — Smith & Nephew, Inc. · Class I
- SutureOut — Bionix, LLC · Class I
- Sklar® — Sklar Corporation · Class I
Cleared under the same submission
K090385 also covers:
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
- Atricure, Inc.
Sources (1)
- FDA UDI 50dd7af9-3477-49f2-aa45-a99b9081792d 36 fields · synced Jun 8, 2026