# K771187: Dermahook #382-805

- Pathway: 510(k) (Traditional)
- Applicant: Edward Weck, Inc.
- Decided: Jul 11, 1977 after 10 days
- Product code: GDG (Hook, Surgical, General & Plastic Surgery)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- May 12, 2008 · Not classified · Z-1856-2008: The bands are breaking within the sealed packaging or in use prior to the expiration dates.
- May 12, 2008 · Not classified · Z-1857-2008: The bands are breaking within the sealed packaging or in use prior to the expiration dates.

Source page: https://510kreport.com/device/K771187
Methodology: https://510kreport.com/methodology