Identifiers
- 510(k) Number
- K973671 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 Endocervical Block Needle is a Set, Anesthesia, Paracervical device, classified under Class II, designed for administering local anesthetic solutions to cervical tissue. It is specifically intended for uterine anesthesia prior to gynecological procedures, facilitating pain control during interventions such as dilation and curettage or cervical biopsies.
This single-use, non-sterile device features a 27-gauge, 3.5-inch hypodermic needle with a 21-gauge proximal shaft reinforcement and a female Luer lock connector for syringe attachment. Supplied as part of a paracervical anesthesia set, it is regulated under FDA 510(k) clearance (K973671) and falls under the Obstetrics/Gynecology medical specialty. Storage and handling must comply with standard sterile medical device protocols prior to use.
Frequently asked questions
What is the Endocervical Block Needle specifically used for in clinical practice?
The Endocervical Block Needle is designed to administer local anesthetic solutions directly to cervical tissue, providing pain control during gynecological procedures such as dilation and curettage or cervical biopsies. It is part of a paracervical anesthesia set and is intended to facilitate uterine anesthesia prior to these interventions.
Is the Endocervical Block Needle intended for single-use or repeated use?
The Endocervical Block Needle is explicitly labeled as a single-use device. This classification ensures patient safety and sterility, as it is not meant to be reused after one procedure.
What needle gauge and length does the Endocervical Block Needle have, and how is it attached to a syringe?
The Endocervical Block Needle features a 27-gauge hypodermic needle with a length of 3.5 inches. It includes a 21-gauge proximal shaft reinforcement for added stability and a female Luer lock connector, allowing secure attachment to a syringe for anesthetic delivery.
How should the Endocervical Block Needle be stored and prepared for use?
While the device is non-sterile as supplied, it must be handled and stored according to standard sterile medical device protocols before use. This includes proper packaging, environmental controls, and adherence to sterile technique to ensure safety during clinical procedures.
What regulatory pathway was followed for FDA clearance of this device?
The Endocervical Block Needle received FDA 510(k) clearance (K973671) under the Traditional Review pathway, with a decision of Substantially Equivalent (SESE). It falls under the Obstetrics/Gynecology medical specialty and is classified as a Class II device, regulated under 21 CFR 884.5100.
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: ENDOCERVICAL BLOCK NEEDLE (K973671) — FDA 510(k) | Innolitics, Endocervical Block Needle 510 (k) K973671 - FDA.report, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K973671 | Class II | Active |
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Manufacturer
- Manufacturer
- A & A Medical, Inc.
Sources (1)
- FDA 510(k) K973671 24 fields · synced Sep 19, 2026