Identity
- Trade Name
- HEARTLINE KNOT PUSHER FORCEPS FDA UDI
- Generic Name
- Suture knot pusher, reusable FDA UDI
- Device Name
- HEARTLINE KNOT PUSHER FORCEPS HOOK & WEDGE SQUEEZE HANDLE FDA UDI
- Model / Reference
- 2800-405L FDA UDI
- Description
- HEARTLINE KNOT PUSHER FORCEPS HOOK & WEDGE SQUEEZE HANDLE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192896010895 FDA UDI
- 510(k) Number
- K152400 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Suture knot pusher, reusable 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
No
FDA UDI
Single Use
No
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 — 29 Centimeter FDA UDI
Category: Suture knot pusher, reusable
Heartline Knot Pusher Forceps by Sontec Instruments, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suture knot pusher, reusable.
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Hayden Medical — Hayden Medical Inc · Class II
- Closed Knot Pusher — Biomet Orthopedics, Inc. · Class I
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- V. Mueller — STERIS CORPORATION · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class II
- VALVE XS — AESCULAP, INC. · Class I
Cleared under the same submission
K152400 also covers:
- HEARTLINE BIOPSY GRASPING FORCEPS — SONTEC INSTRUMENTS, INC.
- HEARTLINE COLVIN NEEDLE HOLDER — SONTEC INSTRUMENTS, INC.
- HEARTLINE COOLEY SCISSORS — SONTEC INSTRUMENTS, INC.
- HEARTLINE CRILEWOOD NEEDLE HOLDER — SONTEC INSTRUMENTS, INC.
- HEARTLINE FLUSHING ADAPTER — SONTEC INSTRUMENTS, INC.
- HEARTLINE JAMESON TENOTOMY SCISSORS — SONTEC INSTRUMENTS, INC.
- HEARTLINE JAMESON TENOTOMY SCISSORS — SONTEC INSTRUMENTS, INC.
- HEARTLINE KNOT PUSHER FORCEPS — SONTEC INSTRUMENTS, INC.
- HEARTLINE MAYO HEGAR NEEDLE HOLDER — SONTEC INSTRUMENTS, INC.
- HEARTLINE MINI IMA HOLDING FORCEPS — SONTEC INSTRUMENTS, INC.
- HEARTLINE MINI JAW NEEDLE HOLDER — SONTEC INSTRUMENTS, INC.
- HEARTLINE RYDER NEEDLE HOLDER — SONTEC INSTRUMENTS, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI fdfaebe5-27e7-490c-abe3-5d8db2036f74 36 fields · synced Jun 8, 2026