510(k) · Cleared
ClearedSpectra Medical Safety Scapel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectra, Inc. · GDZ Handle, Scalpel
Cleared on Dec 15, 2009 after a 211-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Dec 15, 2009
- Review
- 211 days
- Class
- Class I
- Product code
- GDZ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GDZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All GDZ devicesGDZ Handle, Scalpel: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GDZ
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · GDZ
Too few GDZ 510(k)s in any year since 2007 to give a median.
Recalls per year · GDZ
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GDZ
8in 2025
MAUDE reports naming product code GDZ, 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 | 2 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 7 | 5 |
| 2014 | 0 | — | 1 | 3 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 7 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 1 | 5 |
| 2023 | 0 | — | 0 | 10 |
| 2024 | 0 | — | 1 | 15 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Spectra Safety Scalpel is a surgical safety scalpel intended for use as a cutting device during surgical, pathology and minor medical procedures. It is intended to aid in the protection against accidental injuries during loading, passing, and disposal.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K091462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091462: Spectra Medical Safety Scapel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091462
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026