V. Mueller Pneumo-Intestinal 15 Vascular & 30 Stap
FDA 510(k) K854568 · American V. Mueller
510(k) numberK854568
Submission
- Device name
- V. Mueller Pneumo-Intestinal 15 Vascular & 30 Stap
- Applicant
- American V. Mueller
Chicago, IL, US - Received
- November 14, 1985
- Decision date
- December 2, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEF – Applier, Staple, Surgical,
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEF
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| K861471 | V. Mueller Vital Clip-Hemostatic ClipFZP · Traditional | 06/06/1986SE |
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| K851974 | V. Mueller Vital Skin StaplerGDT · Traditional | 06/11/1985SE |
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Questions and answers
When was V. Mueller Pneumo-Intestinal 15 Vascular & 30 Stap cleared by the FDA?
V. Mueller Pneumo-Intestinal 15 Vascular & 30 Stap (K854568) received a 510(k) decision of Substantially Equivalent on December 2, 1985, 18 days after the submission was received.
What is the product code of K854568?
The FDA product code is GEF – Applier, Staple, Surgical,, a Class I (low risk) device regulated under 21 CFR 878.4800.