510(k) · Cleared
ClearedK&W 2-Piece Take-Apart Instruments (Various)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Creative Technologies, Inc. · OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered
Cleared on Sep 10, 1997 after a 12-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 2 later devices descend from it.
- Decided
- Sep 10, 1997
- Review
- 12 days
- Class
- Class II
- Product code
- OCZ
- Recalls
- None
- Predicates
- 1
2 later devices descend from it, 1 citing it directly.
- This deviceK973259 K&W 2-Piece Take-Apart Instruments (Various)Medical Creative Technologies, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK150127 Laparoscopic Handles with peek InsulationStryker Endoscopy · 2015
- Descendant · 2 generations on · 0 of its ownK173272 Ergonomic HandleSymmetry Surgical, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973259 | K&W 2-Piece Take-Apart Instruments (Various) | Medical Creative Technologies, Inc. | 1997 | — |
| +1 | K150127 | Laparoscopic Handles with peek Insulation | Stryker Endoscopy | 2015 | — |
| +2 | K173272 | Ergonomic Handle | Symmetry Surgical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 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 OCZ? 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 OCZ device
- #1 K252800 KARL STORZ Endoscopic Accessories for Urologyscore 11.5 · 1 generation · 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K352148 | Karl Storz Endoscopy America, Inc. devices Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…tter claims equivalence: The devices in consideration are substantially equivalent to the devices currently marketed by Karl Storz Endoscopy America, Inc., under 510(k) K352148. K9732s9 Page 2 of 3 A description of the device that is the subject of the premarket notification submission,… |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150127 | Laparoscopic Handles with peek Insulation | 2015 | 1 |
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, K150127 (Stryker Endoscopy, 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OCZ devicesOCZ Endoscopic Grasping/Cutting Instrument, Non-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OCZ
Too few OCZ 510(k)s in any year since 2007 to give a median.
Recalls per year · OCZ
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCZ
34in 2025
MAUDE reports naming product code OCZ, 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 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 242 |
| 2016 | 1 | — | 0 | 759 |
| 2017 | 0 | — | 0 | 734 |
| 2018 | 0 | — | 0 | 252 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 21 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 17 | 33 |
| 2023 | 0 | — | 0 | 25 |
| 2024 | 1 | — | 0 | 37 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
For use in endoscopic surgical procedures through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions.
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/K973259 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973259: K&W 2-Piece Take-Apart Instruments (Various).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973259
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026