510(k) · Cleared
ClearedPilling Weck 2 Piece Take-Apart Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pilling Weck Group · OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered
Cleared on Mar 4, 1997 as substantially equivalent to K952149 (KARL STORZ Endoscopy-America, Inc., 1995) after a 70-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Mar 4, 1997
- Review
- 70 days
- Class
- Class II
- Product code
- OCZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952149 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK952149 Karl Storz Take-Apart Rotating Grasping ForcepsKARL STORZ Endoscopy-America, Inc. · 1995
- This deviceK965176 Pilling Weck 2 Piece Take-Apart InstrumentsPilling Weck Group · 1997
- Descendant · cites it directly · 0 of its ownK030919 Siss, Inc. (D.B.a.Medisiss) Reprocessd Electrosurgical Instruments…Medisiss · 2003
Most influential descendants
Showing 1 of 1 · See all- K030919Siss, Inc. (D.B.a.Medisiss) Reprocessd Electrosurgical Instruments and AccessoriesMedisiss · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952149 | Karl Storz Take-Apart Rotating Grasping Forceps | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| 0 (this device) | K965176 | Pilling Weck 2 Piece Take-Apart Instruments | Pilling Weck Group | 1997 | — |
| +1 | K030919 | Siss, Inc. (D.B.a.Medisiss) Reprocessd Electrosurgical Instruments and… | Medisiss | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 11.4 · 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K952149 | Karl Storz Take-Apart Rotating Grasping ForcepsSummary 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) K952149. A Teleflex Company One Weck Drive, PO. Box 12600 Research Triangle Park, North Carolina 27709 (919) 544-8000 P… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030919 | Siss, Inc. (D.B.a.Medisiss) Reprocessd Electrosurgical Instruments and Accessories | 2003 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K030919 (Medisiss, 2003) has gone furthest, with 0 descendants 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?
The Pilling Weck 2-Piece Take-Apart Instrumentation is designed to be used endoscopically 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/K965176 · printed Nov 5, 2026
Cite this page
510(k) Report. “K965176: Pilling Weck 2 Piece Take-Apart Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K965176
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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