510(k) · Cleared

Cleared

Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)

K980988510(k) TraditionalCleared May 11, 199855-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

Axya Medical, Inc. · GAB Needle, Suturing, Disposable

Cleared on May 11, 1998 as substantially equivalent to K932591 (Synergistic Medical Technologies, Inc., 1993) after a 55-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it.

Decided: May 11, 1998
Review: 55 days
Class: Class I
Product code: GAB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K932591 (1993). 4 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK932591 Endo-JudgeSynergistic Medical Technologies, Inc. · 1993
This deviceK980988 Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)Axya Medical, Inc. · 1998
Descendant · cites it directly · 3 of its ownK983108 Suture Welding System and Kit (SWK)Axya Medical, Inc. · 1998
Descendant · cites it directly · 1 of its ownK992405 Axya Medical Inc, Bone Anchor System and Kit- (Bak)Axya Medical, Inc. · 1999
Descendant · 2 generations on · 0 of its ownK070253 Axya Suture Welding System and KitAxya Medical, Inc. · 2007
Descendant · cites it directly · 0 of its ownK994313 Modification to Bone Anchor and Kit (Bak)Axya Medical, Inc. · 2000

Most influential descendants

Showing 4 of 4 · See all

K983108Suture Welding System and Kit (SWK)Axya Medical, Inc. · 1998 · cites it directly3descendants
K992405Axya Medical Inc, Bone Anchor System and Kit- (Bak)Axya Medical, Inc. · 1999 · cites it directly1descendant
K070253Axya Suture Welding System and KitAxya Medical, Inc. · 2007 · 2 generations on0descendants
K994313Modification to Bone Anchor and Kit (Bak)Axya Medical, Inc. · 2000 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K932591	Endo-Judge	Synergistic Medical Technologies, Inc.	1993	—
0 (this device)	K980988	Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)	Axya Medical, Inc.	1998	—
+1	K983108	Suture Welding System and Kit (SWK)	Axya Medical, Inc.	1998	—
+1	K992405	Axya Medical Inc, Bone Anchor System and Kit- (Bak)	Axya Medical, Inc.	1999	—
+2	K070253	Axya Suture Welding System and Kit	Axya Medical, Inc.	2007	—
+1	K994313	Modification to Bone Anchor and Kit (Bak)	Axya Medical, Inc.	2000	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2000	1	0
2007	1	0

FIG. 1 — Lineage of K980988, 1993–2007Source: 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 GAB? 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

Get a 510(k) 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K932591	Endo-Judge Summary page 1 …ent in design and function to the Endo-Judge disposable suture placement system developed by Synergistic Medical Technologies and marketed by Ethicon Endosurgery [510(k) K932591], and that it is appropriate for its intended application. Suture applicators and suture placement devices which may be used in b…	Synergistic Medical Technologies, Inc.	1993	—
†	K895252	Ultracision Ultrasonic Scalpel	Ultracision, Inc.	1989	—

Also cleared against K932591: 2 other devices →

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K983108	Suture Welding System and Kit (SWK)	Axya Medical, Inc.	1998	3
K992405	Axya Medical Inc, Bone Anchor System and Kit- (Bak)	Axya Medical, Inc.	1999	1
K994313	Modification to Bone Anchor and Kit (Bak)	Axya Medical, Inc.	2000	0

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?

Its one ancestor has no recall.
Of its descendants, K983108 (Axya Medical, Inc., 1998) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K932591.

How does its category compare?

All GAB devices

GAB Needle, Suturing, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAB

FDA has decided no GAB device since 2007.

Median 510(k) review, days · GAB

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

Recalls per year · GAB

1in 2011

2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · GAB

38in 2025

2007high 59 (2018) · low 5 (2014)2025

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

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	19
2008	—	0	29
2009	—	0	19
2010	—	0	13
2011	—	1	8
2012	—	0	6
2013	—	0	9
2014	—	0	5
2015	—	0	12
2016	—	0	24
2017	—	0	44
2018	—	0	59
2019	—	0	30
2020	—	0	26
2021	—	0	17
2022	—	0	17
2023	—	0	32
2024	—	0	26
2025	—	0	38
2026	—	0	—

What is it indicated for?

The ASLS is indicated for the placement of synthetic monofilament sutures in soft tissues and for the ligation of tubular structures wherever conventional monofilament sutures or surgical staples are appropriate. The ASLS is indicated for use in both traditional open surgery and endoscopic surgical procedures.

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/K980988 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980988: Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980988

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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