Identity
- Trade Name
- NobleStitch EL FDA UDI
- Generic Name
- Suturing unit, single-use FDA UDI
- Device Name
- The NobleStitch™ EL system deploys suture to close an open tissue site in the cardiovascular system, including Patent Foramen Ovale (PFO) closure. The NobleStitch™ EL system consists of two suture delivery devices (one identified as ‘S’, and one identified as ‘P’), and one accessory knot delivery device (identified as ‘KwiKnot™’). The devices work in harmony with each other to place sutures and a knot at the closure site. Also included with the system are other accessories that aid the user in the operation of the devices (accessories may vary). The NobleStitch™ EL suture delivery devices each utilize an arm that is preloaded with 4-0 non-absorbable polypropylene monofilament suture. The NobleStitch™ EL knot delivery ‘KwiKnot™’ device is preloaded with a non-absorbable polypropylene radiopaque knot. The devices do not require any suture or knot loading/manipulation prior to use. The NobleStitch™ EL system operates in the following manner: When a suture end is positioned by the NobleStitch™ EL S suture delivery device arm, a needle is deployed from the device; the deployed needle pierces the closure site tissue and engages the suture end located in the device arm. As the needle is then withdrawn from the arm it captures and retains the suture end. The retained suture end is drawn through the tissue and is retained at the tip of the retracted needle until removed by the user at the appropriate time. The opposite end of the same suture is then free to be removed from the device. The same process is then repeated for a second suture using the NobleStitch™ EL P suture delivery device. Both placed sutures (a total of four suture ends) are then threaded through the KwiKnot™ device. The KwiKnot™ device delivers and engages a two-piece knot to secure the suture at the closure site. FDA UDI
- Model / Reference
- 12-90-07 FDA UDI
- Description
- The NobleStitch™ EL system deploys suture to close an open tissue site in the cardiovascular system, including Patent Foramen Ovale (PFO) closure. The NobleStitch™ EL system consists of two suture delivery devices (one identified as ‘S’, and one identified as ‘P’), and one accessory knot delivery device (identified as ‘KwiKnot™’). The devices work in harmony with each other to place sutures and a knot at the closure site. Also included with the system are other accessories that aid the user in the operation of the devices (accessories may vary). The NobleStitch™ EL suture delivery devices each utilize an arm that is preloaded with 4-0 non-absorbable polypropylene monofilament suture. The NobleStitch™ EL knot delivery ‘KwiKnot™’ device is preloaded with a non-absorbable polypropylene radiopaque knot. The devices do not require any suture or knot loading/manipulation prior to use. The NobleStitch™ EL system operates in the following manner: When a suture end is positioned by the NobleStitch™ EL S suture delivery device arm, a needle is deployed from the device; the deployed needle pierces the closure site tissue and engages the suture end located in the device arm. As the needle is then withdrawn from the arm it captures and retains the suture end. The retained suture end is drawn through the tissue and is retained at the tip of the retracted needle until removed by the user at the appropriate time. The opposite end of the same suture is then free to be removed from the device. The same process is then repeated for a second suture using the NobleStitch™ EL P suture delivery device. Both placed sutures (a total of four suture ends) are then threaded through the KwiKnot™ device. The KwiKnot™ device delivers and engages a two-piece knot to secure the suture at the closure site. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M705129007 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
Yes
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
- Catheter Gauge — 12 French FDA UDI
Category: Suturing unit, single-use
NobleStitch EL by HeartStitch, INC. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- HeartStitch, INC.
Sources (1)
- FDA UDI d74e082c-0ee4-40a4-8017-68951ffd838b 36 fields · synced Jun 1, 2026