Potocky Needle Disposable Injection Needle
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K910252 FDA 510(k)
- FDA Product Code
- HEE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5100 FDA 510(k)
- Regulation Number
- 884.5100 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Potocky Needle is a disposable injection needle designed for injection of solutions into the cervix and vaginal wall. It is used for administering local anesthetics in various office diagnostic and therapeutic procedures. The device is classified as a Set, Anesthesia, Paracervical. The Potocky Needle is a 27-gauge needle specifically designed to solve the problem of applying injections to the cervix of varying length and density.
The Potocky Needle is supplied as a disposable device. It is regulated under the product code HEE and has a device class of 2. The device has been cleared by the FDA under the traditional clearance type with the decision code SESE. It is available with the k number K910252 and fei number 1216677. The device is intended for use in obstetrics and gynecology procedures.
Frequently asked questions
What is the Potocky Needle used for?
The Potocky Needle is used for administering local anesthetics in various office diagnostic and therapeutic procedures, specifically for injection into the cervix and vaginal wall.
Is the Potocky Needle reusable?
No, the Potocky Needle is supplied as a disposable device, intended for single-use.
What gauge is the Potocky Needle?
The Potocky Needle is a 27-gauge needle, specifically designed to solve the problem of applying injections to the cervix of varying length and density.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Potocky Needle® - CooperSurgical, CooperSurgical Potocky Needle | Cervix and Vaginal wall, Potocky Neddle (Tm) Disposable Injection Needle, Cooper Surgical Potocky Needle (6066) | OBGYN Supply, POTOCKY NEDDLE (TM) DISPOSABLE INJECTION NEEDLE (K910252) — FDA 510(k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K910252 | Class II | Active |
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Manufacturer
- Manufacturer
- CooperSurgical, Inc.
Sources (1)
- FDA 510(k) K910252 24 fields · synced Sep 21, 2026