510(k) · Cleared

Cleared

Gentell Hydrogel Spray Gel, Appligard Squeeze

K990440510(k) TraditionalCleared Aug 12, 1999182-day reviewClass U

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

Gentell · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Cleared on Aug 12, 1999 as substantially equivalent to K894541 (Carrington Laboratories, Inc., 1989) and 1 other predicate after a 182-day review. Its family tree reaches back 1 generation to 1989.

Decided: Aug 12, 1999
Review: 182 days
Class: Class U
Product code: MGQ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K894541 (1989). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK894541 Carrington Dermal Wound GelCarrington Laboratories, Inc. · 1989
This deviceK990440 Gentell Hydrogel Spray Gel, Appligard SqueezeGentell · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K894541	Carrington Dermal Wound Gel	Carrington Laboratories, Inc.	1989	—
0 (this device)	K990440	Gentell Hydrogel Spray Gel, Appligard Squeeze	Gentell	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

FIG. 1 — Lineage of K990440, 1989–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 MGQ? 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

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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	Applicant	Decided	Recalls
*	K894541	Carrington Dermal Wound Gel Summary page 1 …ytotoxicity and prescrvative cffcctivencss test. Gentell hydrogel wound and burn dressing is similar in design, composition and function to Carrington Dcrmal Wound Gel (K894541) manufacturcd by Carrington Laboratorics, Inc., and Eutra Gel for Wound Dressing (K932291) manufactured by Swiss American Product…	Carrington Laboratories, Inc.	1989	—
*	K932291	Eutra Gel for Wound Dressing Summary page 1 …is similar in design, composition and function to Carrington Dcrmal Wound Gel (K894541) manufacturcd by Carrington Laboratorics, Inc., and Eutra Gel for Wound Dressing (K932291) manufactured by Swiss American Products, Inc. Hydrogel Wound Drcsting $10(k) Notifization 7 (D o wihiny, (’ -…	Swiss American Products, Inc.	1994	—

Also cleared against K894541: 2 other devices →

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?

None of the 2 ancestors has a recall.
2 other devices also cite its predicate K894541.

How does its category compare?

All MGQ devices

MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MGQ

1in 2017

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MGQ

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

Recalls per year · MGQ

4in 2014

2007high 4 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MGQ

5in 2025

2007high 11 (2024) · low 0 (2008)2025

MAUDE reports naming product code MGQ, 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	0	—	0	0
2009	1	—	0	2
2010	0	—	0	3
2011	0	—	0	5
2012	0	—	0	1
2013	0	—	0	4
2014	0	—	4	10
2015	0	—	0	3
2016	0	—	0	4
2017	1	—	0	6
2018	0	—	0	2
2019	0	—	0	2
2020	0	—	0	6
2021	0	—	0	1
2022	0	—	0	0
2023	0	—	0	6
2024	0	—	0	11
2025	0	—	0	5
2026	0	—	0	—

What is it indicated for?

Pressure ulcers, stage I, II & IV wounds

Venous ulcers

1 & 2nd degree burns

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/K990440 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990440: Gentell Hydrogel Spray Gel, Appligard Squeeze.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990440

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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