# K802093: Gabbay-Frater Suture Guide

- Pathway: 510(k) (Traditional)
- Applicant: Howmedica Corp.
- Decided: Sep 26, 1980 after 24 days
- Product code: FZX (Guide, Surgical, Instrument)
- 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K153076: silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL (2016), 4 descendants of its own
- K192490: Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch (2020), 1 descendant of its own
- K241111: AMT Suture Passer (2024), 0 descendants of its own
- K193530: Deklene MAXX (2020), 0 descendants of its own
- K162396: SILK Surgical Suture (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K802093
Methodology: https://510kreport.com/methodology