Laparette
510(k) K971146
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK971146 | Date25 Aug 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KNF
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.4160
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Laparette is an Endoscopic Unipolar Coagulator-Cutter (Device Type: KNF), designed for obstetrics and gynecology procedures. It combines electrocautery, irrigation, and suction capabilities in a single device, enabling precise tissue coagulation and cutting while maintaining fluid control during minimally invasive surgeries. Its hybrid design integrates reusable components—such as the handle, electrode-cannula, and insulated sleeve—with single-use consumables, including the cartridge and sheath.
The device is supplied as a reusable system with designated single-use accessories, intended for use in endoscopic procedures under MRI-unspecified conditions. It operates via monopolar electrocautery and requires sterile handling of its reusable parts, while single-use components are discarded post-procedure. Authorized under FDA 510(k) clearance (K971146), it adheres to regulatory classification 884.4160 for obstetrics/gynecology devices. Storage and reprocessing protocols for reusable components must comply with manufacturer guidelines to ensure safety and functionality.
Questions
AI-generated answers, 20 Sep 2026
What types of procedures is the Laparette designed to assist with in obstetrics and gynecology?
The Laparette is specifically designed for endoscopic procedures in obstetrics and gynecology, combining electrocautery, irrigation, and suction to enable precise tissue coagulation and cutting. Its hybrid design allows for controlled fluid management during minimally invasive surgeries, making it suitable for applications where tissue manipulation and hemostasis are critical.
How is the Laparette supplied, and what components are reusable versus single-use?
The Laparette is supplied as a reusable system with designated single-use accessories. The reusable components include the handle, electrode-cannula, and insulated sleeve, which require sterile handling. In contrast, the cartridge and sheath are single-use items that must be discarded after each procedure to ensure safety and compliance with manufacturer guidelines.
Does the Laparette require special handling or storage conditions for its reusable parts?
Yes, the reusable parts of the Laparette must be stored and reprocessed according to the manufacturer’s guidelines to maintain safety and functionality. Sterility of reusable components is critical, as they are intended for repeated use across procedures, while single-use accessories are designed for one-time use only.
What regulatory pathway was followed for the Laparette’s clearance, and what classification does it fall under?
The Laparette received FDA clearance through a 510(k) submission (K971146) under the Traditional review pathway, determined to be Substantially Equivalent to a predicate device. It is classified under FDA product code KNF and regulation number 884.4160, which pertains to obstetrics/gynecology devices, specifically an Endoscopic Unipolar Coagulator-Cutter (And Accessories).
Are there any MRI-related considerations for using the Laparette in surgical settings?
The Laparette is intended for use under MRI-unspecified conditions, meaning it is not explicitly designed for MRI-compatible environments. Clinicians should verify compatibility with their specific MRI systems and protocols before use, as the device’s materials or components may not be MRI-safe.