# K990062: Saphlift

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Surgical Product (Genzyme Biosurgery)
- Decided: Mar 30, 1999 after 81 days
- Product code: MDM (Instrument, Manual, Surgical, General Use)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K951854 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951854: Leonard Arm - Support Arm - Endoscopic Accessory, Leonard Medical, Inc. (1995) Summary page 1.
- K973543: Kronner Low Profile Scope Holder, Kronner Prototypes, Inc. (1998) Summary page 1.

## Indications for use
The SAPHLIFT is a holding and manipulating arm for use in surgery which allows the operating team to hold manual surgical instruments and the SaphLite Retractor in a given position and to change that position immediately with one hand.

Source page: https://510kreport.com/device/K990062
Methodology: https://510kreport.com/methodology