Identity
- Trade Name
- C1® DEVICE FDA UDI
- Generic Name
- Suturing unit, single-use FDA UDI
- Device Name
- C1® SUTURING DEVICE (ANGLED SHAFT) FDA UDI
- Model / Reference
- 022000 FDA UDI
- Description
- C1® SUTURING DEVICE (ANGLED SHAFT) FDA UDI
Identifiers
- Catalog Number
- 022000 FDA UDI
- Primary DI / UDI-DI
- 00850200006308 FDA UDI
- 510(k) Number
- K100593 FDA UDI
- FDA Product Code
- HCF FDA UDI
- GMDN Term
- Suturing unit, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Dimensions & Sizes
- Size
- Outer Diameter — 5 Millimeter FDA UDI
Category: Suturing unit, single-use
C1® Device by LSI Solutions, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K100593 also covers:
- C1® DEPTH LIMITER — LSI Solutions, Inc.
- C1® DEVICE — LSI Solutions, Inc.
- COR-KNOT MINI® — LSI Solutions, Inc.
- COR-KNOT MINI® — LSI Solutions, Inc.
- COR-KNOT® — LSI Solutions, Inc.
- COR-KNOT® — LSI Solutions, Inc.
- COR-KNOT® QUICK LOAD® — LSI Solutions, Inc.
- COR-KNOT® QUICK LOAD® — LSI Solutions, Inc.
- COR-SUTURE® QUICK LOAD® — LSI Solutions, Inc.
- COR-SUTURE® QUICK LOAD® — LSI Solutions, Inc.
- COR-SUTURE® QUICK LOAD® — LSI Solutions, Inc.
- INTRA-KNOT® — LSI Solutions, 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 I | Pending data |
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Manufacturer
- Manufacturer
- LSI Solutions, Inc.
Sources (1)
- FDA UDI 647ca239-8c13-406e-aa85-2763bc1f3742 37 fields · synced May 30, 2026