510(k) Report

510(k) · Cleared

Cleared

Flex Endoscopic Instruments

K140662510(k) TraditionalCleared Jun 11, 201489-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

Design Standards Corp. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Jun 11, 2014 as substantially equivalent to K091869 (Covidien Lp, Formerly Registered AS United States, 2009) and 4 other predicates after an 89-day review. Its family tree reaches back 2 generations to 1990.

Decided
Jun 11, 2014
Review
89 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K904578 (1990). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestor1994: 1 other ancestor1992: 2 other ancestors1991: 2 other ancestorsK904578 · Modification Auto Suture (R) Endoscopic Clamp · United States Surgical, A Division of Tyco Healthc · 1990K091869 · Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils Shears · Covidien Lp, Formerly Registered AS United States · 2009199019952000200520102015
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 2 other ancestors K091869 · Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils Shears · Covidien Lp, Formerly Registered AS United States · 2009K904578 · Modification Auto Suture (R) Endoscopic Clamp · United States Surgical, A Division of Tyco Healthc · 19900
  1. Root · 2 generations backK904578 Modification Auto Suture (R) Endoscopic ClampUnited States Surgical, A Division of Tyco Healthc · 1990
  2. 1 generation backK091869 Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsCovidien Lp, Formerly Registered AS United States · 2009
  3. This deviceK140662 Flex Endoscopic InstrumentsDesign Standards Corp. · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K904578Modification Auto Suture (R) Endoscopic ClampUnited States Surgical, A Division of Tyco Healthc1990—
−1K091869Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils ShearsCovidien Lp, Formerly Registered AS United States2009—
0 (this device)K140662Flex Endoscopic InstrumentsDesign Standards Corp.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199120
199220
199410
199510
FIG. 1 — Lineage of K140662, 1990–2014Source: 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 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. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 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? (5)

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
*K091869Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils Shears
Summary page 1
…n Number(s): 21 CER 876.1500 Endoscope and Accessories Predicate Device: Covidien SILSTM and Endoscopic Hand Instruments (K091869, K95 1589, K914752) Microsurge, Inc. Endoseopic Laser Fiber Holder (K91…
Covidien Lp, Formerly Registered AS United States2009—
*K951589Manual Surgical Insrument
Summary page 1
…s): 21 CER 876.1500 Endoscope and Accessories Predicate Device: Covidien SILSTM and Endoscopic Hand Instruments (K091869, K95 1589, K914752) Microsurge, Inc. Endoseopic Laser Fiber Holder (K912332)…
United States Surgical, A Division of Tyco Healthc1995—
*K914752Auto Suture (R) Articulating Endoscopic Scissors
Summary page 1
…21 CER 876.1500 Endoscope and Accessories Predicate Device: Covidien SILSTM and Endoscopic Hand Instruments (K091869, K95 1589, K914752) Microsurge, Inc. Endoseopic Laser Fiber Holder (K912332)…
United States Surgical, A Division of Tyco Healthc1992—
*K912332Microsurge Laser Fiber Holder
Summary page 1
…ments (K091869, K95 1589, K914752) Microsurge, Inc. Endoseopic Laser Fiber Holder (K912332) United States Surgical Corporation, Endloscopic Needle Driver (K933725…
Microsurge, Inc.1991—
*K933725Endoscopic Needle Driver
Summary page 1
…er Holder (K912332) United States Surgical Corporation, Endloscopic Needle Driver (K933725) Intended Use: The FlexTM Monopolar Maryland Dissector is a single use electrosurgical device intended to be used in conjunctio…
United States Surgical, A Division of Tyco Healthc1994—

Also cleared against K091869: 4 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 24 years and passes through 3 companies; a new generation was cleared every 18.8 years on median.
  • None of the 8 ancestors has a recall.
  • 4 other devices also cite its predicate K091869.

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. 2014, this device’s year, is highlighted.

FDA decisions per year · GCJ

21in 2025

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
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

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

What is it indicated for?

The FlexTM Monopolar Maryland Dissector is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue. The FlexTM Monopolar Needle Knife is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical…

Read the full statement (208 words)

The FlexTM Monopolar Maryland Dissector is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.

The FlexTM Monopolar Needle Knife is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.

The FlexTM Monopolar Spatula is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.

The FlexTM Needle Driver is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue.

The FlexTM Fenestrated Grasper is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue.

The FlexTM Monopolar Scissor is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting of tissue.

The FlexTM Laser Fiber Holder is a single use endoscopic device with applications in endoscopic surgical procedures to house and introduce a laser fiber.

Indications for use as stated in the FDA summary.

Also cleared against K091869

4 other devices cite the same predicate.

  • K203603Monopolar HookHuman Xtensions, Ltd. · 2021
  • K200501ArtiSential Laparoscopic Instrument-ElectrodesLivsmed, Inc. · 2020
  • K122532DA Vinci Single-Site Instruments and AccessoriesIntuitive Surgical, Inc. · 20136 recalls
  • K122299Spider Surgical Instruments, Flexible Monopolar Grasper Wavy Ratcheted, Spider Surgical Instruments…Transenterix, Inc. · 2012

More from Design Standards Corp.

2 FDA decisions under this applicant name. See the company

  • K040602Sureline Laparoscopic Clip Applier with Implantable Titanium ClipsDesign Standards Corp. · 2004

Recent decisions in GCJ

The GCJ category page

  • K262455da Vinci 5 Handheld Camera Head (470080);da Vinci 5 Handheld Camera Laparoscope, 0 degree (470081);da Vinci…Intuitive Surgical, Inc. · 2026
  • K262397CuratOR EX2742Eizo Corporation · 2026
  • K260884UNIDRIVE Select SystemKarl Storz SE & CO. KG · 2026
  • K260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony Corporation · 2026
  • K261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLC · 2026

https://510kreport.com/device/K140662 · printed Nov 4, 2026

Cite this page

510(k) Report. “K140662: Flex Endoscopic Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140662

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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