Surgical Lift Sheet
FDA 510(k) K942807 · Surgin Surgical Instrumentation, Inc.
510(k) numberK942807
Submission
- Device name
- Surgical Lift Sheet
- Applicant
- Surgin Surgical Instrumentation, Inc.
Tustin, CA, US - Received
- June 14, 1994
- Decision date
- August 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FSA – Lift, Patient, Non-Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5510
- Specialty
- General Hospital
Other 510(k)s with product code FSA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K930625 | Sanitas Patient LiftFSA · Traditional | Dutton-Lainson Co. | 09/13/1993SE |
| K902141 | Anolift - Portable & Anolift - GantryFSA · Traditional | Anodyne Corp. | 09/12/1990SE |
| K860837 | Hoyer One-Touch Power LifterFSA · Traditional | Ted Hoyer & Co., Inc. | 03/27/1986SE |
| K851844 | MoliftFSA · Traditional | Madshus A/S | 05/17/1985SE |
| K844976 | Medi-Man Water Powered Bath Lift & Hydraulic LiftFSA · Traditional | Medi-Man Rehabilitation Products, Inc. | 04/01/1985SE |
| K841398 | Variable Height Transfer ChairFSA · Traditional | Setma, Inc. | 05/07/1984SE |
| K841395 | Shower TrolleyFSA · Traditional | Setma, Inc. | 05/07/1984SE |
| K840997 | Battery Powered Patient LiftFSA · Traditional | Invacare Corp. | 04/17/1984SE |
| K823206 | Martin Pelvic LiftFSA · Traditional | Martin Pelvic Lift Co. | 04/28/1983SE |
| K811899 | Century Lift Transfer SystemFSA · Traditional | Century Manufacturing Co. | 07/23/1981SE |
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| K980849 | Surgin KitMSR · Traditional | 07/09/1998SE |
| K954238 | Surgin Genisis HandpieceHQC · Traditional | 12/08/1995SE |
| K950600 | Vacuum Surge SupresserHQC · Traditional | 05/10/1995SE |
| K942945 | Cassette System for StorzHQC · Traditional | 12/05/1994SE |
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Questions and answers
When was Surgical Lift Sheet cleared by the FDA?
Surgical Lift Sheet (K942807) received a 510(k) decision of Substantially Equivalent on August 2, 1994, 49 days after the submission was received.
What is the product code of K942807?
The FDA product code is FSA – Lift, Patient, Non-Ac-Powered, a Class I (low risk) device regulated under 21 CFR 880.5510.