Identity
- Trade Name
- Polysorb FDA UDI
- Generic Name
- Suture knot-tying device FDA UDI
- Device Name
- Absorbable Single Stitch Reload FDA UDI
- Model / Reference
- 170073 FDA UDI
- Description
- Absorbable Single Stitch Reload FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20884521126807 FDA UDI
- 510(k) Number
- K934738 FDA UDI
- FDA Product Code
- OCW FDA UDI
- GMDN Term
- Suture knot-tying device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 48 Inch FDA UDI
Category: Suture knot-tying device
Polysorb by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suture knot-tying device.
- TenSURE — ATRICURE, INC. · Class I
- TenSURE — ATRICURE, INC. · Class I
- TenSURE — ATRICURE, INC. · Class I
- PEAK MEDICAL — PEAK MEDICAL Distribution Inc · Class I
- TenSURE — ATRICURE, INC. · Class I
- Polysorb — Covidien LP · Class II
- Polysorb — Covidien LP · Class II
- Surgidac — Covidien LP · Class II
Cleared under the same submission
K934738 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI 3ba8f61d-e359-4d3a-9ec1-d4a5fd939559 37 fields · synced May 31, 2026