Henke Sass Wolf Saphenous Vein Laparoscope
FDA 510(k) K013611 · Henke Sass Wolf of America, Inc.
510(k) numberK013611
Submission
- Device name
- Henke Sass Wolf Saphenous Vein Laparoscope
- Applicant
- Henke Sass Wolf of America, Inc.
Flemington, NJ, US - Received
- November 5, 2001
- Decision date
- February 1, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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More from TroCare, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K080560 | Henke Sass Wolf of America ArthroscopeHRX · Traditional | 03/18/2008SE |
| K050163 | Henke Sass Wolf of America Bariatric LaparoscopeGCJ · Traditional | 03/24/2005SE |
| K030572 | Henke Sass Wolf of America NasopharyngoscopeEOB · Traditional | 04/01/2003SE |
| K991563 | Continuous Flow Hystero-Resectoscope, Knife Electrode, Spike Electrode, Vaporisation…HIH · Traditional | 10/13/1999SE |
| K983067 | Fine-JectFMI · Traditional | 10/30/1998SE |
| K981751 | Sinuscope and AccessoriesEOB · Traditional | 08/13/1998SE |
| K962075 | HSW GmbH ArthroscopeHRX · Traditional | 01/17/1997SE |
| K941541 | HSV Laparoscopy SetGCJ · Traditional | 05/16/1994SE |
Questions and answers
When was Henke Sass Wolf Saphenous Vein Laparoscope cleared by the FDA?
Henke Sass Wolf Saphenous Vein Laparoscope (K013611) received a 510(k) decision of Substantially Equivalent on February 1, 2002, 88 days after the submission was received.
What is the product code of K013611?
The FDA product code is GCJ – Laparoscope, General & Plastic Surgery, a Class II (moderate risk) device regulated under 21 CFR 876.1500.