Chermel Bone Gouges

K842822510(k) TraditionalCleared Aug 2, 198414-day reviewClass I21 CFR 878.4800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cher Mel Corp. · GDH Gouge, Surgical, General & Plastic Surgery

Cleared on Aug 2, 1984 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided: Aug 2, 1984
Review: 14 days
Class: Class I
Product code: GDH
Recalls: None
Predicates: 0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K842822Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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 GDH devices

GDH Gouge, Surgical, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDH

FDA has decided no GDH device since 2007.

Median 510(k) review, days · GDH

Too few GDH 510(k)s in any year since 2007 to give a median.

Recalls per year · GDH

No recall names GDH since 2007.

Adverse event reports per year · GDH

2in 2024

2007high 13 (2017) · low 0 (2008)2025

MAUDE reports naming product code GDH, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	5
2008	—	0
2009	—	2
2010	—	1
2011	—	2
2012	—	2
2013	—	2
2014	—	7
2015	—	12
2016	—	7
2017	—	13
2018	—	3
2019	—	4
2020	—	2
2021	—	5
2022	—	2
2023	—	2
2024	—	2
2025	—	0
2026	—	—

https://510kreport.com/device/K842822 · printed Nov 6, 2026

Cite this page

510(k) Report. “K842822: Chermel Bone Gouges.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K842822

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Record history

FDA decision record loaded May 2, 2026
Page last updated Nov 3, 2026