WALLACH INTEGRATION UNIT— 510(k) K963348
Substantially EquivalentWallach Surgical Devices, Inc.
FDA 510(k) clearance K963348 for WALLACH INTEGRATION UNIT, Substantially Equivalent on 1997-03-19. Applicant: Wallach Surgical Devices, Inc.. Device class: 2.
Clearance details
- Applicant
- Wallach Surgical Devices, Inc.
- Product code
- Code HGI
- Device class
- Class 2
- Regulation
- 21 CFR 884.4120
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milford, CT, US
Recent devices under product code HGI
view allMore clearances from Wallach Surgical Devices, Inc.
view allAdverse events under product code HGI
product code HGI- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K963348
K-number listed on FDA's recall record- Z-0257-2022 — LEEP PRECISION Integrated System, 120V CooperSurgical part number: LP-10-120
- Z-0258-2022 — LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220
- Z-2057-2019 — LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120
- Z-1840-2019 — LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The loop electrosurgical excision procedure (LEEP) utilizes a very thin wire in the shape of a loop heated by electrical current generated by a power supply to efficiently remove abnormal cells. The LEEP PRECISION INTEGRATED SYSTEM has been designed to provide an efficient workstation that can efficiently meet all the unique LEEP requirements of the clinic and practice-based facilities .
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K963348.
Data sourced from openFDA. This site is unofficial and independent of the FDA.