Transfer Trolley
FDA 510(k) K841396 · Setma, Inc.
510(k) numberK841396
Submission
- Device name
- Transfer Trolley
- Applicant
- Setma, Inc.
Mchenry, IL, US - Received
- April 3, 1984
- Decision date
- May 7, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FDA – Enteroscope And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To provide visualization and perform various procedures within the small intestine. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (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 Fujifilm Medical Systems U.S.A, Inc.
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|---|---|---|
| K854861 | Setma Hygia Bath Model ST 7200ILJ · Traditional | 01/03/1986SE |
| K854263 | Setma FHT, Model ST 8130ILJ · Traditional | 11/13/1985SE |
| K853163 | Setma VHTILJ · Traditional | 11/05/1985SE |
| K841397 | Burn BathILJ · Traditional | 05/18/1984SE |
| K841398 | Variable Height Transfer ChairFSA · Traditional | 05/07/1984SE |
| K841395 | Shower TrolleyFSA · Traditional | 05/07/1984SE |
Questions and answers
When was Transfer Trolley cleared by the FDA?
Transfer Trolley (K841396) received a 510(k) decision of Substantially Equivalent on May 7, 1984, 34 days after the submission was received.
What is the product code of K841396?
The FDA product code is FDA – Enteroscope And Accessories, a Class II (moderate risk) device regulated under 21 CFR 876.1500.