510(k) Report

510(k) · Cleared

Cleared

Inman Endoscopic Blunt Dissector

K933169510(k) TraditionalCleared Apr 19, 1994294-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

Inman Medical Corp. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Apr 19, 1994 after a 294-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 265 devices in its family, counting itself, has a Class I recall. 264 later devices descend from it.

Decided
Apr 19, 1994
Review
294 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
0

264 later devices descend from it, 1 citing it directly. 1 of the 265 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1997: 1 descendant cleared2002: 3 descendants cleared2004: 4 descendants cleared2009: 3 descendants cleared2008: 6 descendants cleared2005: 5 descendants cleared2014: 11 descendants cleared2006: 3 descendants cleared2011: 6 descendants cleared2010: 1 descendant cleared2018: 18 descendants cleared2025: 31 descendants cleared2024: 22 descendants cleared2017: 15 descendants cleared2022: 18 descendants cleared2013: 6 descendants cleared2019: 12 descendants cleared2012: 4 descendants cleared2016: 11 descendants cleared2020: 19 descendants cleared2021: 17 descendants cleared2015: 6 descendants cleared2026: 23 descendants cleared2023: 19 descendants cleared, 1 with a Class I recall11990200020102020
  1. This deviceK933169 Inman Endoscopic Blunt DissectorInman Medical Corp. · 1994
  2. Descendant · cites it directly · 263 of its ownK965001 Intuitive Surgical Monarch Laparoscopic ManipulatorIntuitive Surgical, Inc. · 1997
  3. Descendant · 2 generations on · 260 of its ownK022574 Intuitive Surgical Endoscopic Instrument Control System & Endoscopic…Intuitive Surgical, Inc. · 2002
  4. Descendant · 2 generations on · 260 of its ownK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
  5. Descendant · 2 generations on · 258 of its ownK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
  6. Descendant · 2 generations on · 254 of its ownK013416 Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc. · 2002

Showing 5 of 264 descendants. See all descendants

Descendants cleared per year

1997: 12002: 32004: 42005: 52006: 32008: 62009: 32010: 12011: 62012: 42013: 62014: 112015: 62016: 112017: 152018: 182019: 122020: 192021: 172022: 182023: 192024: 222025: 312026: 23
1997high 31 (2025) · low 0 (1998)2026

Class I recalls in this family

  • K223095 Senhance Surgical System5 generations on · 2023

Most influential descendants

Showing 5 of 264 · See all
  • K965001Intuitive Surgical Monarch Laparoscopic ManipulatorIntuitive Surgical, Inc. · 1997 · cites it directly263descendants
  • K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…Intuitive Surgical, Inc. · 2002 · 2 generations on260descendants
  • K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · 2 generations on260descendants
  • K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…Intuitive Surgical, Inc. · 2004 · 2 generations on258descendants
  • K013416Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc. · 2002 · 2 generations on254descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933169Inman Endoscopic Blunt DissectorInman Medical Corp.1994—
+1K965001Intuitive Surgical Monarch Laparoscopic ManipulatorIntuitive Surgical, Inc.1997—
+2K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic…Intuitive Surgical, Inc.2002—
+2K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc.200218
+2K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc.2004—
+2K013416Intuitive Surgical Endowrist Endoscopic Instrument FamilyIntuitive Surgical, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200230
200440
200550
200630
200860
200930
201010
201160
201240
201360
2014110
201560
2016110
2017150
2018180
2019120
2020190
2021170
2022180
2023191
2024220
2025310
2026230
FIG. 1 — Lineage of K933169, 1994–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (264)

See all 264

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

NumberDeviceApplicantDecidedDescendants
K965001Intuitive Surgical Monarch Laparoscopic ManipulatorIntuitive Surgical, Inc.1997263

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K223095Senhance Surgical SystemAsensus Surgical, Inc. · 2023 · 5 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K965001 (Intuitive Surgical, Inc., 1997) has gone furthest, with 263 descendants of its own.

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—

More from Inman Medical Corp.

14 FDA decisions under this applicant name. See the company

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  • K933382Imc Cable/Wire CoverInman Medical Corp. · 1994
  • K933774Imc Saline Wet DressingInman Medical Corp. · 1993
  • K933305Imc 5.0MM Irrigation/Aspiration ProbeInman Medical Corp. · 1993

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The GCJ category page

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https://510kreport.com/device/K933169 · printed Nov 6, 2026

Cite this page

510(k) Report. “K933169: Inman Endoscopic Blunt Dissector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933169

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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