# K902307: Shaw II Hemostatic Surgery System

- Pathway: 510(k) (Traditional)
- Applicant: Hemostatic Surgery Corp.
- Decided: Aug 17, 1990 after 87 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
226 later devices descend from it; 2 cite it directly.
0 of 227 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
- K993714: Memograph Staple, Warm System (2000), 222 descendants of its own
- K011716: The Uni-Clip Staple (2001), 117 descendants of its own
- K070031: Memometal Memory Staples (2007), 114 descendants of its own
- K061594: Large Uni-Clip Staple (2006), 103 descendants of its own
- K070447: Newdeal Compression Plate (2007), 102 descendants of its own

## Recalls of this device
- Jul 27, 2010 · Not classified · Z-2595-2010: Lack of sterility assurance
- Jul 27, 2010 · Not classified · Z-2596-2010: Lack of sterility assurance

Source page: https://510kreport.com/device/K902307
Methodology: https://510kreport.com/methodology