Identity
- Trade Name
- Endo Paddle Retract FDA UDI
- Generic Name
- Self-retaining surgical retractor, single-use FDA UDI
- Device Name
- Paddle Retractor FDA UDI
- Model / Reference
- 173046 FDA UDI
- Description
- Paddle Retractor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884523000771 FDA UDI
- 510(k) Number
- K914190 FDA UDI
- FDA Product Code
- GAD FDA UDI
- GMDN Term
- Self-retaining surgical retractor, 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 — 12 Millimeter FDA UDI
Category: Self-retaining surgical retractor, single-use
Endo Paddle Retract by Covidien LP — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Self-retaining surgical retractor, single-use.
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- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- VALVE XS — AESCULAP, INC. · Class I
- Sklar® — Sklar Corporation · Class I
Cleared under the same submission
K914190 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Covidien LP
Sources (1)
- FDA UDI be6f027f-ce5b-415f-9111-dcfbf1499e83 37 fields · synced Jun 8, 2026