Wallach Integration Unit
FDA 510(k) K963348 · Wallach Surgical Devices, Inc.
510(k) numberK963348
Submission
- Device name
- Wallach Integration Unit
- Applicant
- Wallach Surgical Devices, Inc.
Milford, CT, US - Received
- August 26, 1996
- Decision date
- March 19, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HGI – Electrocautery, Gynecologic (And Accessories)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4120
- Specialty
- Obstetrics/Gynecology
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| K152843 | Liger Medical HTU-110HGI · Traditional | Liger Medical, LLC | 06/24/2016SE |
| K130606 | Fmwand Ferromagnetic Surgical SystemHGI · Traditional | Domain Surgical, Inc. | 01/03/2014SE |
| K121881 | Domain Surgical SystemHGI · Traditional | Domain Surgical, Inc. | 10/18/2012SE |
| K070877 | Endocervical Electrode # 2HGI · Traditional | Modern Medical Equipment Mfg., Ltd. | 07/27/2007SE |
| K061651 | Fischer Cone Biopsy Excisor, Models 900-150, 151, 152, 154, 155, 157 and 158HGI · Traditional | Apple Medical Corp. | 10/20/2006SE |
| K022593 | Thomas Medical ElectrodesHGI · Traditional | Thomas Medical, Inc. | 11/01/2002SE |
| K003608 | Sovereign Bipolar Instruments for GynecologyHGI · Traditional | Aesculap, Inc. | 02/20/2001SE |
| K002042 | Trucone Rotational Cone Biopsy Instrument, Model 231812 - 233018HGI · Traditional | New England Medical Corp. | 02/01/2001SE |
| K993527 | Loop Electrode, Ball ElectrodeHGI · Traditional | Palm Medical USA, Inc. | 07/06/2000SE |
More from Palm Medical USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K021224 | Endocervical Block NeedleHEE · Traditional | 07/12/2002SE |
| K020711 | Wallach Loop ElectrodeGEI · Traditional | 06/03/2002SE |
| K000768 | Wallach Quantum 500 Electrosurgical GeneratorEKZ · Traditional | 04/11/2000SE |
| K992736 | Wallach's Ultimate Reusable, Plastic Vaginal SpeculumHIB · Traditional | 09/29/1999SE |
| K991669 | PMS 750 FingerswitchGEI · Traditional | 08/12/1999SE |
| K983840 | Wallach Quantum 500 Electrosurgical Generator (Proposed)HGI · Traditional | 05/20/1999SE |
| K984306 | `The Inseminator' (Proposed)MFD · Traditional | 03/01/1999SE |
| K983208 | Wallach Quantum 500 Electrosurgical GeneratorGEI · Traditional | 02/22/1999SE |
| K963653 | Wallach Quantum 2000 Electrosurgical SystemHGI · Traditional | 06/11/1997SE |
| K950630 | Wallach Digital Imaging SystemLMB · Traditional | 11/22/1995SE |
Questions and answers
When was Wallach Integration Unit cleared by the FDA?
Wallach Integration Unit (K963348) received a 510(k) decision of Substantially Equivalent on March 19, 1997, 205 days after the submission was received.
What is the product code of K963348?
The FDA product code is HGI – Electrocautery, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.4120.