510(k) · Cleared
ClearedWiggins Medical Surgical Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wiggins Medical · HAE Rongeur, Manual
Cleared on Jul 21, 2020 as substantially equivalent to K153243 (Fehling Instruments GmbH & Co. KG, 2016) and 1 other predicate after a 154-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Jul 21, 2020
- Review
- 154 days
- Class
- Class II
- Product code
- HAE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K902819 (1990). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK902819 Laminectomy RogeurRuggles Corp. · 1990
- 3 generations backK092227 Jarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - Kerrison…Integra Lifesciences Corp. · 2010
- 2 generations backK150428 Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles…Integra Lifesciences Corp. · 2015
- 1 generation backK153243 Fehling-PunchesFehling Instruments GmbH & Co. KG · 2016
- This deviceK200383 Wiggins Medical Surgical InstrumentsWiggins Medical · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902819 | Laminectomy Rogeur | Ruggles Corp. | 1990 | — |
| −3 | K092227 | Jarit, Ruggles, R&B Redmond/ Redmond, Miltex, Meisterhand - Kerrison Rongeurs | Integra Lifesciences Corp. | 2010 | — |
| −2 | K150428 | Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM)… | Integra Lifesciences Corp. | 2015 | — |
| −1 | K153243 | Fehling-Punches | Fehling Instruments GmbH & Co. KG | 2016 | — |
| 0 (this device) | K200383 | Wiggins Medical Surgical Instruments | Wiggins Medical | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 HAE? 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 HAE device
- #1 K260446 Tontarra Punches and Rongeursscore 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K153243 | Fehling-PunchesSummary page 4…ss I Reviewing Panel: Neurology, Orthopedic Product Code: HAE, HTX Predicate Device: Fehling Punches (K153243) Integra Kerrison Rongeurs (K150428) The predicate… | 2016 |
| * | K150428 | Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison…Summary page 4…oduct Code: HAE, HTX Predicate Device: Fehling Punches (K153243) Integra Kerrison Rongeurs (K150428) The predicate device has never been subject to recall. Device Description:… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- None of the 5 ancestors has a recall.
- 4 other devices also cite its predicate K153243.
How does its category compare?
All HAE devicesHAE Rongeur, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · HAE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAE
270in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAE
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HAE
10in 2025
MAUDE reports naming product code HAE, 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 | 2 | — | 0 | 4 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 2 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 31 |
| 2012 | 2 | — | 0 | 47 |
| 2013 | 2 | — | 0 | 20 |
| 2014 | 0 | — | 0 | 15 |
| 2015 | 1 | — | 0 | 25 |
| 2016 | 4 | 270 | 0 | 34 |
| 2017 | 0 | — | 0 | 25 |
| 2018 | 1 | — | 0 | 29 |
| 2019 | 0 | — | 0 | 24 |
| 2020 | 2 | — | 0 | 25 |
| 2021 | 1 | — | 0 | 12 |
| 2022 | 2 | — | 0 | 13 |
| 2023 | 2 | — | 2 | 10 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Wiggins Medical Surgical Instruments are manually operated, reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.
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/K200383 · printed Nov 5, 2026
Cite this page
510(k) Report. “K200383: Wiggins Medical Surgical Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K200383
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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