Panpac Disposable Vacuum Curettes
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161106 FDA 510(k)
- FDA Product Code
- HGH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5070 FDA 510(k)
- Regulation Number
- 884.5070 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Panpac Disposable Vacuum Curettes are uterine suction cannulas designed for the transcervical aspiration of the uterine cavity. These medical instruments function as suction tools to facilitate gynecological procedures.
This device is intended for single-use by healthcare professionals in clinical settings. It has received FDA 510(k) clearance under the product code HGH.
Frequently asked questions
What is the intended use of the Panpac Disposable Vacuum Curettes?
These instruments are designed for the transcervical aspiration of the uterine cavity. They function as suction tools to assist healthcare professionals in performing various gynecological procedures.
Are these curettes intended for multiple uses?
No, the Panpac Disposable Vacuum Curettes are intended for single-use only. This design ensures that each procedure is performed with a sterile, unused instrument to maintain clinical safety standards.
What is the regulatory status of this device?
The Panpac Disposable Vacuum Curettes have received FDA 510(k) clearance under the product code HGH. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.
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: PANPAC DISPOSABLE VACUUM CURETTES (K161106) — FDA 510(k) | Innolitics, PANPAC DISPOSABLE VACUUM CURETTES by PANPAC MEDICAL CORPORATION | FDA ..., PANPAC DISPOSABLE VACUUM CURETTES - FDA K161106 - Pure Global AI
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161106 | Class II | Active |
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Manufacturer
- Manufacturer
- Panpac Medical Corporation
Sources (1)
- FDA 510(k) K161106 24 fields · synced Sep 21, 2026