510(k) Report

510(k) · Decided

Decided

Gesco Catheterization Tray

K882647510(k) TraditionalDecided Sep 9, 198874-day reviewClass I21 CFR 878.4200

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

Gesco Intl., Inc. · GBQ Catheter, Continuous Irrigation

Cleared on Sep 9, 1988 after a 74-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Sep 9, 1988
Review
74 days
Class
Class I
Product code
GBQ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K882647Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 GBQ devices

GBQ Catheter, Continuous Irrigation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GBQ

FDA has decided no GBQ device since 2007.

Median 510(k) review, days · GBQ

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

Recalls per year · GBQ

No recall names GBQ since 2007.

Adverse event reports per year · GBQ

6in 2025

2010: 12011: 22014: 22016: 12017: 12018: 12019: 22020: 92021: 12022: 72023: 322024: 72025: 6
2007high 32 (2023) · low 0 (2007)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—01
20110—02
20120—00
20130—00
20140—02
20150—00
20160—01
20170—01
20180—01
20190—02
20200—09
20210—01
20220—07
20230—032
20240—07
20250—06
20260—0—

More from Gesco Intl., Inc.

26 FDA decisions under this applicant name. See the company

  • K954422Per-Q-Cath Mid-LineGesco Intl., Inc. · 1995
  • K940870Umbili-CathGesco Intl., Inc. · 1994
  • K940953Umbili-Cath-SGesco Intl., Inc. · 1994
  • K940952Umbili-Cath-S-DLGesco Intl., Inc. · 1994
  • K941672Uri-Cath CatheterGesco Intl., Inc. · 1994

Recent decisions in GBQ

The GBQ category page

  • K941356Microflow Irrigation SystemJedmed Instrument Co. · 1994
  • K921464Cat.#40100, 40102, 40104 & 40106 Yankauer Suct IntTrinity Laboratories, Inc. · 1992
  • K874596Perforated Soaking TubeSpecialty Medical Products Co. · 1987
  • K873097Procedual Changes/Assembly Process for Plus PaksIpax, Inc. · 1987
  • K872787Modified CurlcathQuinton, Inc. · 1987

https://510kreport.com/device/K882647 · printed Nov 6, 2026

Cite this page

510(k) Report. “K882647: Gesco Catheterization Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K882647

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