510(k) Report

510(k) · Cleared

Cleared

Superstitch

K994087510(k) TraditionalCleared Mar 1, 200089-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

Sutura, Inc. · OCW Endoscopic Tissue Approximation Device

Cleared on Mar 1, 2000 as substantially equivalent to K963965 (Cardiothoracic Systems, Inc., 1998) and 2 other predicates after an 89-day review. Its family tree reaches back 1 generation to 1993. 2 later devices descend from it.

Decided
Mar 1, 2000
Review
89 days
Class
Class II
Product code
OCW
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K925149 (1993). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1994: 1 other ancestor2001: 1 descendant cleared2002: 1 descendant clearedK925149 · Auto Suture Endoscopic Knot Pusher · United States Surgical, A Division of Tyco Healthc · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K925149 · Auto Suture Endoscopic Knot Pusher · United States Surgical, A Division of Tyco Healthc · 19930
  1. Root · 1 generation backK925149 Auto Suture Endoscopic Knot PusherUnited States Surgical, A Division of Tyco Healthc · 1993
  2. This deviceK994087 SuperstitchSutura, Inc. · 2000
  3. Descendant · cites it directly · 1 of its ownK012865 Superstitch Vascular Suturing DeviceSutura, Inc. · 2001
  4. Descendant · 2 generations on · 0 of its ownK020940 Superstitch Vascular Suturing Device, 6 French, Models 06-15-00X…Sutura, Inc. · 2002

Most influential descendants

Showing 2 of 2 · See all
  • K012865Superstitch Vascular Suturing DeviceSutura, Inc. · 2001 · cites it directly1descendant
  • K020940Superstitch Vascular Suturing Device, 6 French, Models 06-15-00X; Mid-Length 06-25-00XSutura, Inc. · 2002 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K925149Auto Suture Endoscopic Knot PusherUnited States Surgical, A Division of Tyco Healthc1993—
0 (this device)K994087SuperstitchSutura, Inc.2000—
+1K012865Superstitch Vascular Suturing DeviceSutura, Inc.2001—
+2K020940Superstitch Vascular Suturing Device, 6 French, Models 06-15-00X; Mid-Length…Sutura, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
FIG. 1 — Lineage of K994087, 1993–2002Source: 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), 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 OCW? 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 OCW device

  1. #1 K252400 Endomina EZFuse systemscore 12.0 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K963965CTS Midcab Stitcher
Summary page 4
…manufacturers. The technological characteristics of the SuperStitch® and accessory Knot Pusher are substantially equivalent to the following devices: Vascular Stitcher (K963965), CardioThoracic Systems, Inc. AutoSuture™ Endoscopic Suturing Device (K934738), U.S. Surgical Corporation AutoSuture Endoscopi…
Cardiothoracic Systems, Inc.1998—
*K934738Autosuture Endoscopic Suturing Device
Summary page 4
…ry Knot Pusher are substantially equivalent to the following devices: Vascular Stitcher (K963965), CardioThoracic Systems, Inc. AutoSuture™ Endoscopic Suturing Device (K934738), U.S. Surgical Corporation AutoSuture Endoscopic Knot Pusher™ (K925149), U S. Surgical Corporation Indication for Use: SuperS…
United States Surgical, A Division of Tyco Healthc19942
*K925149Auto Suture Endoscopic Knot Pusher
Summary page 4
…scular Stitcher (K963965), CardioThoracic Systems, Inc. AutoSuture™ Endoscopic Suturing Device (K934738), U.S. Surgical Corporation AutoSuture Endoscopic Knot Pusher™ (K925149), U S. Surgical Corporation Indication for Use: SuperStitch® is indicated for use in performing vascular stitching in general s…
United States Surgical, A Division of Tyco Healthc1993—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K012865Superstitch Vascular Suturing DeviceSutura, Inc.20011

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?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K012865 (Sutura, Inc., 2001) has gone furthest, with 1 descendant of its own.

How does its category compare?

All OCW devices

OCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OCW

1in 2025

2007: 52008: 42009: 32010: 42011: 12012: 12013: 22016: 22017: 22018: 22019: 12020: 12021: 32023: 32025: 12026 (partial year): 2
2007high 5 (2007) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCW

133in 2023

2007: 58 days median2008: 70 days median2009: 30 days median2010: 91 days median2021: 221 days median2023: 133 days median
2007high 221 (2021) · low 30 (2009)2026

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

Recalls per year · OCW

3so far in 2026, the most since 2007

2023: 12026 (partial year): 3
2007high 3 (2026) · low 0 (2007)2026

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

Adverse event reports per year · OCW

326in 2025

2007: 92008: 472009: 302010: 102011: 162012: 282013: 22014: 282015: 592016: 742017: 4202018: 4132019: 2912020: 1832021: 1982022: 2352023: 2272024: 2112025: 326
2007high 420 (2017) · low 2 (2013)2025

MAUDE reports naming product code OCW, 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
200755809
2008470047
2009330030
2010491010
20111—016
20121—028
20132—02
20140—028
20150—059
20162—074
20172—0420
20182—0413
20191—0291
20201—0183
202132210198
20220—0235
202331331227
20240—0211
20251—0326
20262—3—

What is it indicated for?

SuperStitch® is indicated for use in performing vascular stitching in general surgery, including endoscopic procedures. It is not intended for blind vascular closure.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Sutura, Inc.

5 FDA decisions under this applicant name. See the company

  • K062125Superstitch 5F, 12F, and ELSutura, Inc. · 2006
  • K053482Superstitch GW, Models 06-15-04-GW, 08-15-04-GWSutura, Inc. · 2005
  • K020940Superstitch Vascular Suturing Device, 6 French, Models 06-15-00X; Mid-Length 06-25-00XSutura, Inc. · 2002
  • K012865Superstitch Vascular Suturing DeviceSutura, Inc. · 2001

Recent decisions in OCW

The OCW category page

  • K262044Mediclose Cartridge SystemHealth Value Creation B.V. (trading as Corporis Medical) · 2026
  • K252400Endomina EZFuse systemEndo Tools Therapeutics S.A. · 2026
  • K243750SimpleStitch Suturing SystemEnvision Endoscopy · 2025
  • K231240MaxTack™ Motorized Fixation DeviceCovidien · 2023
  • K213271MedicloseTM SystemHealth Value Creation B.V., Trading AS Corporis Medical · 2023

https://510kreport.com/device/K994087 · printed Nov 4, 2026

Cite this page

510(k) Report. “K994087: Superstitch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994087

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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