Touriquet Kit with Snare
FDA 510(k) K855144 · Dlp, Inc.
510(k) numberK855144
Submission
- Device name
- Touriquet Kit with Snare
- Applicant
- Dlp, Inc.
Grand Rapids, MI, US - Received
- December 26, 1985
- Decision date
- February 5, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GDJ – Clamp, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
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| K895726 | Vessel OccluderGDJ · Traditional | Applied Medical Technologies | 10/24/1989SE |
| K895591 | Silicone Instrument ShodsGDJ · Traditional | Key Surgical, Inc. | 10/20/1989SE |
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Questions and answers
When was Touriquet Kit with Snare cleared by the FDA?
Touriquet Kit with Snare (K855144) received a 510(k) decision of Substantially Equivalent on February 5, 1986, 41 days after the submission was received.
What is the product code of K855144?
The FDA product code is GDJ – Clamp, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.