510(k) · Cleared
ClearedFlexigel-G Hydrogel Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Technologies, Ltd. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Mar 4, 1998 after a 51-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Mar 4, 1998
- Review
- 51 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K920097 | FDA’s K920097 is MRT-50 QD Head Coil Our OCR of the scanned summary read K920097, FDA’s number for MRT-50 QD Head Coil (Toshiba America Mri, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Intrasite™ Gel”. Kept off the family tree. Summary page 1…assification Name: Common / Usual Name: Contact: Prepared: FlexiGel-G Hydrogel Wound Dressing KMF Liquid Bandage Hydrogel Wound Dressing Innovative Technologies Ltd K 92009 7 Priscilla Whitehead Cox, Director of Regulatory Affairs Thursday, January 8, 1998 FlexiGel-G Amorphous Hydrogel Wound Dressing… | 1992 |
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 MGQ devicesMGQ 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
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGQ
5in 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?
FlexiGel-G™ Hydrogel Wound Dressing may be used for the management of partial to full thickness wounds e.g.:
Pressure Ulcers
Venous Stasis Ulcers
Diabetic Ulcers
1st and 2nd Degree Burns
Surgical Wounds
Trauma Wounds
Dermal Lesions (Cuts, abrasions, etc)
FlexiGel-G™ Hydrogel Wound Dressing may be used for the management of wounds such as:
Superficial cuts
Abrasions
Lacerations
Minor scalds
Minor burns
Minor skin irritations
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/K980097 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980097: Flexigel-G Hydrogel Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980097
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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