510(k) Report

510(k) · Cleared

Cleared

Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture Cartridge

K073671510(k) TraditionalCleared Mar 26, 200890-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

Ndo Surgical, Inc. · OCW Endoscopic Tissue Approximation Device

Cleared on Mar 26, 2008 as substantially equivalent to K071553 (Ndo Surgical, Inc., 2007) and 7 other predicates after a 90-day review. Its family tree reaches back 5 generations to 1997. 3 later devices descend from it.

Decided
Mar 26, 2008
Review
90 days
Class
Class II
Product code
OCW
Recalls
None
Predicates
8

Its longest line of descent runs back 5 generations to K972679 (1997). 13 ancestors in all, the oldest K934738 (1994). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 2 other ancestors2003: 2 other ancestors2001: 2 other ancestors2006: 1 other ancestor1994: 1 other ancestor2010: 1 descendant cleared2011: 1 descendant cleared2012: 1 descendant clearedK972679 · Endopath Endoscopic Tissue Fastening System (Etfs) · Ethicon Endo-Surgery, Inc. · 1997K980022 · Endopath Endoscopic Tissue Fastening System (Etfs) · Ethicon Endo-Surgery, Inc. · 1998K994290 · Bard Endoscopic Suturing System · C.R. Bard, Inc. · 2000K062875 · Endogastric Stomaphyx Device and Accessories · Endogastric Solutions, Inc. · 2007K070151 · Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting Element Applier · Ethicon Endo-Surgery, LLC · 20071990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K070151 · Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting Element Applier · Ethicon Endo-Surgery, LLC · 2007K062875 · Endogastric Stomaphyx Device and Accessories · Endogastric Solutions, Inc. · 2007K994290 · Bard Endoscopic Suturing System · C.R. Bard, Inc. · 2000K980022 · Endopath Endoscopic Tissue Fastening System (Etfs) · Ethicon Endo-Surgery, Inc. · 1998K972679 · Endopath Endoscopic Tissue Fastening System (Etfs) · Ethicon Endo-Surgery, Inc. · 1997−50
  1. Root · 5 generations backK972679 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1997
  2. 4 generations backK980022 Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc. · 1998
  3. 3 generations backK994290 Bard Endoscopic Suturing SystemC.R. Bard, Inc. · 2000
  4. 2 generations backK062875 Endogastric Stomaphyx Device and AccessoriesEndogastric Solutions, Inc. · 2007
  5. 1 generation backK070151 Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and…Ethicon Endo-Surgery, LLC · 2007
  6. This deviceK073671 Plicator GSX Suturing System, Plicator GSX, Plicator Instrument…Ndo Surgical, Inc. · 2008
  7. Descendant · cites it directly · 2 of its ownK082044 Ace Stapler, Model F0031Barosense, Inc. · 2010
  8. Descendant · 2 generations on · 1 of its ownK110829 Ace Stapler and CartridgeBarosense, Inc. · 2011
  9. Descendant · 3 generations on · 0 of its ownK120147 Ace Stapler and CartridgeBarosense, Inc. · 2012

Most influential descendants

Showing 3 of 3 · See all
  • K082044Ace Stapler, Model F0031Barosense, Inc. · 2010 · cites it directly2descendants
  • K110829Ace Stapler and CartridgeBarosense, Inc. · 2011 · 2 generations on1descendant
  • K120147Ace Stapler and CartridgeBarosense, Inc. · 2012 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K972679Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc.1997—
−4K980022Endopath Endoscopic Tissue Fastening System (Etfs)Ethicon Endo-Surgery, Inc.1998—
−3K994290Bard Endoscopic Suturing SystemC.R. Bard, Inc.2000—
−2K062875Endogastric Stomaphyx Device and AccessoriesEndogastric Solutions, Inc.2007—
−1K070151Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting…Ethicon Endo-Surgery, LLC2007—
0 (this device)K073671Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX…Ndo Surgical, Inc.2008—
+1K082044Ace Stapler, Model F0031Barosense, Inc.2010—
+2K110829Ace Stapler and CartridgeBarosense, Inc.2011—
+3K120147Ace Stapler and CartridgeBarosense, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
200120
200320
200610
200720

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201210
FIG. 1 — Lineage of K073671, 1997–2012Source: FDA 510(k) summaries, read by 510(k) Report · 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), 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
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What was it cleared against? (8)

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
*K071553Endoscopic Plication System; Eps; Plicator
Our OCR of the scanned summary read K071533, FDA’s number for Fitmate Series (Cosmed Srl). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “NDQ Surgical Plicator™ Endoscopic Plication System”.
Ndo Surgical, Inc.2007—
*K072125Endoscopic Plication System, Eps, Eplicator, Plicator Instrument
Summary page 4
…on Name: Endoscope accessory Classification Name: Endoscope and accessories Class: II 3. PREDICATE DEVICE: NDQ Surgical Plicator™ Endoscopic Plication System (K071533; K072125) Bard® EndoCinch™ Suturing System (K994290; K003956) EndoGastric StomaphyX Device and Accessories (K062875) InScope Tissue Appo…
Ndo Surgical, Inc.2007—
*K994290Bard Endoscopic Suturing System
Summary page 4
…Name: Endoscope and accessories Class: II 3. PREDICATE DEVICE: NDQ Surgical Plicator™ Endoscopic Plication System (K071533; K072125) Bard® EndoCinch™ Suturing System (K994290; K003956) EndoGastric StomaphyX Device and Accessories (K062875) InScope Tissue Apposition System (K070151) 4. DEVICE DESCRIPT…
C.R. Bard, Inc.2000—
*K003956Bard Endocinch Suturing System # 000452; 000454; 000595
Summary page 4
…doscope and accessories Class: II 3. PREDICATE DEVICE: NDQ Surgical Plicator™ Endoscopic Plication System (K071533; K072125) Bard® EndoCinch™ Suturing System (K994290; K003956) EndoGastric StomaphyX Device and Accessories (K062875) InScope Tissue Apposition System (K070151) 4. DEVICE DESCRIPTION: The…
C.R. Bard, Inc.2001—
*K062875Endogastric Stomaphyx Device and Accessories
Summary page 4
…NDQ Surgical Plicator™ Endoscopic Plication System (K071533; K072125) Bard® EndoCinch™ Suturing System (K994290; K003956) EndoGastric StomaphyX Device and Accessories (K062875) InScope Tissue Apposition System (K070151) 4. DEVICE DESCRIPTION: The Plicator GSX Suturing System (GSX) deploys a pledgeted,…
Endogastric Solutions, Inc.2007—
*K070151Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting Element Applier
Summary page 4
…System (K071533; K072125) Bard® EndoCinch™ Suturing System (K994290; K003956) EndoGastric StomaphyX Device and Accessories (K062875) InScope Tissue Apposition System (K070151) 4. DEVICE DESCRIPTION: The Plicator GSX Suturing System (GSX) deploys a pledgeted, suture to approximate and secure tissue wit…
Ethicon Endo-Surgery, LLC2007—
*K023234Endoscopic Plication System
Summary page 5
…or GSX™ Suturing System (GSX), is identical in design, materials and fundamental operating principles to the predicate Plicator Endoscopic Plication System (EPS) device (K023234, K032820, K071533), except that: e the Plicator GSX pre-tied, pledgeted suture will be offered in two different lengths (the EPS…
Ndo Surgical, Inc.2003—
*K032820Modification to Endoscopic Plication System
Summary page 5
…uturing System (GSX), is identical in design, materials and fundamental operating principles to the predicate Plicator Endoscopic Plication System (EPS) device (K023234, K032820, K071533), except that: e the Plicator GSX pre-tied, pledgeted suture will be offered in two different lengths (the EPS only offe…
Ndo Surgical, Inc.20031

Also cleared against K071553: 3 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K082044Ace Stapler, Model F0031Barosense, Inc.20102

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 11 years and passes through 5 companies; a new generation was cleared every 7 months on median.
  • 3 of the 13 ancestors have a recall of any class.
  • Of its descendants, K082044 (Barosense, Inc., 2010) has gone furthest, with 2 descendants of its own.
  • 3 other devices also cite its predicate K071553.

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. 2008, this device’s year, is highlighted.

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?

The Plicator GSX™ Suturing System is indicated for the endoscopic placement of sutures to approximate and fixate gastrointestinal soft tissue.

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

Also cleared against K071553

3 other devices cite the same predicate.

  • K233240GERDX-SystemG-Surg GmbH · 2024
  • K120299SRS Endoscopic Stapling SystemMedigus, Ltd. · 2012
  • K072125Endoscopic Plication System, Eps, Eplicator, Plicator InstrumentNdo Surgical, Inc. · 2007

More from Ndo Surgical, Inc.

6 FDA decisions under this applicant name. See the company

  • K072125Endoscopic Plication System, Eps, Eplicator, Plicator InstrumentNdo Surgical, Inc. · 2007
  • K071553Endoscopic Plication System; Eps; PlicatorNdo Surgical, Inc. · 2007
  • K032820Modification to Endoscopic Plication SystemNdo Surgical, Inc. · 20031 recall
  • K031262Endoscopic Plication System, Model 160-00760Ndo Surgical, Inc. · 2003
  • K023234Endoscopic Plication SystemNdo Surgical, Inc. · 2003

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/K073671 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073671: Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073671

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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