510(k) · Cleared
ClearedTacker, Model R65-933
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A & A Medical, Inc. · OCW Endoscopic Tissue Approximation Device
Cleared on Jul 25, 2001 after a 216-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jul 25, 2001
- Review
- 216 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK003949 Tacker, Model R65-933A & A Medical, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK060329 Endofast Reliant SystemEndogun Medical Systems · 2006
- Descendant · 2 generations on · 1 of its ownK080836 Modification to Endofast Reliant SystemEndogun Medical Systems · 2008
- Descendant · 3 generations on · 0 of its ownK130059 Endofast Reliant SCP, Endofast Reliant LapIbi Israel Biomedical Innovations, Ltd. · 2013
Most influential descendants
Showing 3 of 3 · See all- K060329Endofast Reliant SystemEndogun Medical Systems · 2006 · cites it directly2descendants
- K080836Modification to Endofast Reliant SystemEndogun Medical Systems · 2008 · 2 generations on1descendant
- K130059Endofast Reliant SCP, Endofast Reliant LapIbi Israel Biomedical Innovations, Ltd. · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003949 | Tacker, Model R65-933 | A & A Medical, Inc. | 2001 | — |
| +1 | K060329 | Endofast Reliant System | Endogun Medical Systems | 2006 | — |
| +2 | K080836 | Modification to Endofast Reliant System | Endogun Medical Systems | 2008 | — |
| +3 | K130059 | Endofast Reliant SCP, Endofast Reliant Lap | Ibi Israel Biomedical Innovations, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OCW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OCW device
- #1 K252400 Endomina EZFuse systemscore 12.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Origin Tacker system Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060329 | Endofast Reliant System | 2006 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060329 (Endogun Medical Systems, 2006) has gone furthest, with 2 descendants of its own.
How does its category compare?
All OCW devicesOCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCW
133in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCW
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCW
326in 2025
MAUDE reports naming product code OCW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 58 | 0 | 9 |
| 2008 | 4 | 70 | 0 | 47 |
| 2009 | 3 | 30 | 0 | 30 |
| 2010 | 4 | 91 | 0 | 10 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 28 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 2 | — | 0 | 74 |
| 2017 | 2 | — | 0 | 420 |
| 2018 | 2 | — | 0 | 413 |
| 2019 | 1 | — | 0 | 291 |
| 2020 | 1 | — | 0 | 183 |
| 2021 | 3 | 221 | 0 | 198 |
| 2022 | 0 | — | 0 | 235 |
| 2023 | 3 | 133 | 1 | 227 |
| 2024 | 0 | — | 0 | 211 |
| 2025 | 1 | — | 0 | 326 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K003949 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003949: Tacker, Model R65-933.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003949
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026