510(k) · Cleared

Cleared

Modification to Multaport Cannula, Reducer and Accessories

K990379510(k) SpecialCleared Mar 4, 199924-day reviewClass II21 CFR 876.1500

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

Dexide, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Mar 4, 1999 as substantially equivalent to K981941 (Dexide, Inc., 1998) after a 24-day review. Its family tree reaches back 2 generations to 1991.

Decided: Mar 4, 1999
Review: 24 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K912980 (1991). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK912980 Monoscopy Brand 5MM Lock Trocar Sleeve, ModifiedDexide, Inc. · 1991
1 generation backK981941 Multaport Cannula Reducer and AccessoriesDexide, Inc. · 1998
This deviceK990379 Modification to Multaport Cannula, Reducer and AccessoriesDexide, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K912980	Monoscopy Brand 5MM Lock Trocar Sleeve, Modified	Dexide, Inc.	1991	—
−1	K981941	Multaport Cannula Reducer and Accessories	Dexide, Inc.	1998	—
0 (this device)	K990379	Modification to Multaport Cannula, Reducer and Accessories	Dexide, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

FIG. 1 — Lineage of K990379, 1991–1999Source: 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 GCJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GCJ device

#1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K981941	Multaport Cannula Reducer and Accessories Summary page 1 …nula, Reducer Seal, and Spike Classification Name: Laparoscopic, General & Plastic Surgery 3) Predicate Device: Dexide Inc., MultAport™ Cannula, Reducer and Accessories, K981941 4) Description of Device: The “candidate device” is a reusable, stainless steel Cannula and disposable, single-use reduction se…	Dexide, Inc.	1998	—

Also cleared against K981941: 3 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?

The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 7.0 years on median.
None of the 3 ancestors has a recall.
3 other devices also cite its predicate K981941.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCJ

21in 2025

2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007high 122 (2010) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GCJ

5in 2025

2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, 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	18	42	12	1,639
2008	19	73	16	1,319
2009	21	85	6	1,995
2010	24	122	30	2,657
2011	15	113	9	2,133
2012	17	88	1	1,526
2013	15	93	7 (1)	1,565
2014	19	90	2	1,714
2015	26	76	0	1,710
2016	27	99	5	2,080
2017	20	77	1	3,468
2018	21	88	1	2,562
2019	15	60	0	2,578
2020	28	61	0	2,618
2021	18	116	0	3,431
2022	20	103	1	3,945
2023	31	109	1	6,002
2024	29	90	0	6,047
2025	21	108	5	5,860
2026	26	122	1	—

What is it indicated for?

MultAport Cannulas: The MultAport reusable cannula is used with an AccuPort Seal or Orbital Reducer Seal and Trocar Spike for creating a point of entry for laparoscopic instruments into the abdominal cavity. AccuPort 5-12mm Seal: The AccuPort Seal is a single-use device used during laparoscopy with MultAport Cannulas to maintain pneumoperitoneum while accommodating instruments with diameters ranging from 5mm to 12mm. Orbital Reducer Seal: The Orbital…

Read the full statement (209 words)

MultAport Cannulas:

The MultAport reusable cannula is used with an AccuPort Seal or Orbital Reducer Seal and Trocar Spike for creating a point of entry for laparoscopic instruments into the abdominal cavity.

AccuPort 5-12mm Seal:

The AccuPort Seal is a single-use device used during laparoscopy with MultAport Cannulas to maintain pneumoperitoneum while accommodating instruments with diameters ranging from 5mm to 12mm.

Orbital Reducer Seal:

The Orbital Reducer is a single use-device used during laparoscopy with MultAport Cannulas to maintain pneumoperitoneum while accommodating instruments of equal and smaller size.

Blunt Spike:

The reusable Blunt Trocar spike is used with the MultAport Cannulas and AccuPort or Orbital Reducer Seal for creating a point of entry for laparoscopic instruments into the abdominal cavity.

Sealing Cone:

The Sealing Cone is a reusable product designed for use during open laparoscopy procedures. Used in conjunction with the MultAport Cannula and Blunt Spike, the Sealing Cone provides a means to maintain pneumoperitoneum.

Shaft Seal (replacement part for Sealing Cone):

The Sealing Cone is a reusable product designed for used during open laparoscopy procedures. Used in conjunction with the MultAport Cannula and Blunt Spike, the Sealing Cone provides a means to maintain pneumoperitoneum. The shaft seal is designed for use when sealing the cone to the cannula.

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/K990379 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990379: Modification to Multaport Cannula, Reducer and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990379

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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