Identity
- Trade Name
- Hobbs Posi-Stop Injection Needle FDA UDI
- Generic Name
- General-purpose endoscopic needle, single-use FDA UDI
- Device Name
- A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device. FDA UDI
- Model / Reference
- 4712S FDA UDI
- Description
- A flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device. FDA UDI
Identifiers
- Catalog Number
- 4712S FDA UDI
- Primary DI / UDI-DI
- M8494712S0 FDA UDI
- 510(k) Number
- K834403 FDA UDI
- FDA Product Code
- FBK FDA UDI
- GMDN Term
- General-purpose endoscopic needle, single-use 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose endoscopic needle, single-use
Hobbs Posi-Stop Injection Needle by Hobbs Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose endoscopic needle, single-use.
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- Injectra, ScleroTip — Medi-Globe Corporation · Class II
- Single Use Injector NM600/610 — Olympus Medical Systems Corporation · Class II
- Single Use Aspiration Needle NA-U401SX — Olympus Medical Systems Corporation · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class I
Cleared under the same submission
K834403 also covers:
- Hobbs Posi-Stop Injection Needle — HOBBS MEDICAL, INC.
- Hobbs Posi-Stop Injection Needle — HOBBS MEDICAL, INC.
- Hobbs Posi-Stop Injection Needle — HOBBS MEDICAL, INC.
- Hobbs Posi-Stop Injection Needle — HOBBS MEDICAL, INC.
- Hobbs Posi-Stop Injection Needle — HOBBS MEDICAL, INC.
- Hobbs Posi-Stop Injection Needle — HOBBS MEDICAL, INC.
- Hobbs Posi-Stop Injection Needle — HOBBS MEDICAL, INC.
- Hobbs Posi-Stop Injection Needle — HOBBS MEDICAL, INC.
- Hobbs Posi-Stop Injection Needle — HOBBS MEDICAL, INC.
- Hobbs Posi-Stop Injection Needle — HOBBS MEDICAL, INC.
- Hobbs Posi-Stop Injection Needle — HOBBS MEDICAL, INC.
- Hobbs Posi-Stop Injection Needle — HOBBS MEDICAL, 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
- Hobbs Medical, Inc.
Sources (1)
- FDA UDI 144fc23f-520c-4a8d-8766-a5d1f6aebb12 36 fields · synced May 31, 2026