510(k) Report

510(k) · Cleared

Cleared

Endo-Judge

K932591510(k) TraditionalCleared Dec 22, 1993208-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

Synergistic Medical Technologies, Inc. · GAB Needle, Suturing, Disposable

Cleared on Dec 22, 1993 after a 208-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.

Decided
Dec 22, 1993
Review
208 days
Class
Class I
Product code
GAB
Recalls
None
Predicates
0

5 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared1998: 2 descendants cleared2000: 1 descendant cleared2007: 1 descendant cleared1990200020102020
  1. This deviceK932591 Endo-JudgeSynergistic Medical Technologies, Inc. · 1993
  2. Descendant · cites it directly · 4 of its ownK980988 Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)Axya Medical, Inc. · 1998
  3. Descendant · cites it directly · 3 of its ownK983108 Suture Welding System and Kit (SWK)Axya Medical, Inc. · 1998
  4. Descendant · cites it directly · 1 of its ownK992405 Axya Medical Inc, Bone Anchor System and Kit- (Bak)Axya Medical, Inc. · 1999
  5. Descendant · 2 generations on · 0 of its ownK070253 Axya Suture Welding System and KitAxya Medical, Inc. · 2007
  6. Descendant · 2 generations on · 0 of its ownK994313 Modification to Bone Anchor and Kit (Bak)Axya Medical, Inc. · 2000

Most influential descendants

Showing 5 of 5 · See all
  • K980988Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)Axya Medical, Inc. · 1998 · cites it directly4descendants
  • 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 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932591Endo-JudgeSynergistic Medical Technologies, Inc.1993—
+1K980988Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)Axya Medical, Inc.1998—
+1K983108Suture Welding System and Kit (SWK)Axya Medical, Inc.1998—
+1K992405Axya Medical Inc, Bone Anchor System and Kit- (Bak)Axya Medical, Inc.1999—
+2K070253Axya Suture Welding System and KitAxya Medical, Inc.2007—
+2K994313Modification to Bone Anchor and Kit (Bak)Axya Medical, Inc.2000—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
199910
200010
200710
FIG. 1 — Lineage of K932591, 1993–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

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
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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? (5)

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

NumberDeviceApplicantDecidedDescendants
K980988Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)Axya Medical, Inc.19984
K983108Suture Welding System and Kit (SWK)Axya Medical, Inc.19983
K992405Axya Medical Inc, Bone Anchor System and Kit- (Bak)Axya Medical, Inc.19991

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?

  • Of its descendants, K980988 (Axya Medical, Inc., 1998) has gone furthest, with 4 descendants of its own.

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

2011: 1
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

2007: 192008: 292009: 192010: 132011: 82012: 62013: 92014: 52015: 122016: 242017: 442018: 592019: 302020: 262021: 172022: 172023: 322024: 262025: 38
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—019
20080—029
20090—019
20100—013
20110—18
20120—06
20130—09
20140—05
20150—012
20160—024
20170—044
20180—059
20190—030
20200—026
20210—017
20220—017
20230—032
20240—026
20250—038
20260—0—

Recent decisions in GAB

The GAB category page

  • K012199DigicapHumana USA, Inc. · 2001
  • K980988Axya Medical, Inc. Automatic Suturing and Ligating System-(Asls)Axya Medical, Inc. · 1998
  • K895681Contrast Background MaterialApplied Medical Technologies · 1989
  • K863595Coated Suture NeedleSharpoint, Inc. · 1986
  • K831648Anchor Brand Surgical NeedlesAnchor Products Co. · 1983

https://510kreport.com/device/K932591 · printed Nov 5, 2026

Cite this page

510(k) Report. “K932591: Endo-Judge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K932591

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