# K003949: Tacker, Model R65-933

- Pathway: 510(k) (Traditional)
- Applicant: A & A Medical, Inc.
- Decided: Jul 25, 2001 after 216 days
- Product code: OCW (Endoscopic Tissue Approximation Device)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Origin Tacker system: named in the summary without a submission number

## Most influential descendants
- K060329: Endofast Reliant System (2006), 2 descendants of its own
- K080836: Modification to Endofast Reliant System (2008), 1 descendant of its own
- K130059: Endofast Reliant SCP, Endofast Reliant Lap (2013), 0 descendants of its own

## Indications for use
This device is indicated for use in endoscopic surgery procedures for urethropexy, including fixation of prostatic material, approximation of tissues in various surgical specialties, such as repair of hernias and bladder neck suspension.

Source page: https://510kreport.com/device/K003949
Methodology: https://510kreport.com/methodology