510(k) Report

510(k) · Cleared

Cleared

Iotec Trocar and Flexible Cannula

K970888510(k) TraditionalCleared Jan 9, 1998304-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

Iotec Industries · GCJ Laparoscope, General & Plastic Surgery

Cleared on Jan 9, 1998 as substantially equivalent to K940587 (Access Surgical Intl., Inc., 1994) and 1 other predicate after a 304-day review. Its family tree reaches back 1 generation to 1993.

Decided
Jan 9, 1998
Review
304 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K931111 (1993). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestorK931111 · Endopath Disposable Flexible Surgical Cannula · Ethicon Endo-Surgery, Inc. · 1993199019921994199619982000
Other ancestors, by generation 1 generation back: 1 other ancestor K931111 · Endopath Disposable Flexible Surgical Cannula · Ethicon Endo-Surgery, Inc. · 19930
  1. Root · 1 generation backK931111 Endopath Disposable Flexible Surgical CannulaEthicon Endo-Surgery, Inc. · 1993
  2. This deviceK970888 Iotec Trocar and Flexible CannulaIotec Industries · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K931111Endopath Disposable Flexible Surgical CannulaEthicon Endo-Surgery, Inc.1993—
0 (this device)K970888Iotec Trocar and Flexible CannulaIotec Industries1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
FIG. 1 — Lineage of K970888, 1993–1998Source: 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
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What was it cleared against? (2)

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
*K940587Flex-I-Port
Summary page 1
…Roger Cooper Executive Vice President Regulatory Affairs Monday, 3 March 1997 Totec Trocar and Flexible Cannula Trocar and Flexible Cannula Access Surgical Intl. Inc. K940587 Ethicon, Inc. K931111 The Iotec Trocar and Flexible Cannula is composed of Plastic, Stainless Steel (or plastic rod) for attachm…
Access Surgical Intl., Inc.1994—
*K931111Endopath Disposable Flexible Surgical Cannula
Summary page 1
…Vice President Regulatory Affairs Monday, 3 March 1997 Totec Trocar and Flexible Cannula Trocar and Flexible Cannula Access Surgical Intl. Inc. K940587 Ethicon, Inc. K931111 The Iotec Trocar and Flexible Cannula is composed of Plastic, Stainless Steel (or plastic rod) for attachment of the trocar tip;…
Ethicon Endo-Surgery, Inc.1993—

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?

  • None of the 2 ancestors has a recall.

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.

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 product is intended to create a point of entry for curved endoscopic instruments into the abdominal and chest cavities during a endoscopic procedure.

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

Recent decisions in GCJ

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https://510kreport.com/device/K970888 · printed Nov 6, 2026

Cite this page

510(k) Report. “K970888: Iotec Trocar and Flexible Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970888

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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