510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Reusable Laparoscopic Instruments

K930667510(k) TraditionalCleared May 16, 1994461-day reviewClass II21 CFR 876.1500Recalls 15

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Snowden-Pencer · GCJ Laparoscope, General & Plastic Surgery

Cleared on May 16, 1994 after a 461-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 of the 280 devices in its family, counting itself, have a Class I recall. 279 later devices descend from it. It has been recalled 15 times.

Decided
May 16, 1994
Review
461 days
Class
Class II
Product code
GCJ
Recalls
15
Predicates
0

279 later devices descend from it, 4 citing it directly. 2 of the 280 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2010: 3 descendants cleared, 1 with a Class I recall12011: 9 descendants cleared1996: 1 descendant cleared2016: 12 descendants cleared2012: 5 descendants cleared2002: 5 descendants cleared1998: 1 descendant cleared2000: 1 descendant cleared1997: 1 descendant cleared2006: 3 descendants cleared2004: 4 descendants cleared2009: 3 descendants cleared2001: 1 descendant cleared2008: 6 descendants cleared2005: 5 descendants cleared2014: 12 descendants cleared2018: 18 descendants cleared2025: 31 descendants cleared2024: 22 descendants cleared2017: 15 descendants cleared2022: 18 descendants cleared2013: 7 descendants cleared2019: 12 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 deviceK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994
  2. Descendant · cites it directly · 273 of its ownK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
  3. Descendant · 2 generations on · 269 of its ownK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
  4. Descendant · 3 generations on · 260 of its ownK022574 Intuitive Surgical Endoscopic Instrument Control System & Endoscopic…Intuitive Surgical, Inc. · 2002
  5. Descendant · 3 generations on · 260 of its ownK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
  6. Descendant · 3 generations on · 258 of its ownK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004

Showing 5 of 279 descendants. See all descendants

Descendants cleared per year

1996: 11997: 11998: 12000: 12001: 12002: 52004: 42005: 52006: 32008: 62009: 32010: 32011: 92012: 52013: 72014: 122015: 62016: 122017: 152018: 182019: 122020: 192021: 172022: 182023: 192024: 222025: 312026: 23
1996high 31 (2025) · low 0 (1999)2026

Class I recalls in this family

  • K092684 Laparoscopic Retractorscites it directly · 2010
  • K223095 Senhance Surgical System5 generations on · 2023

Most influential descendants

Showing 5 of 279 · See all
  • K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port…Snowden-Pencer · 1996 · cites it directly273descendants
  • K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…Intuitive Surgical, Inc. · 2000 · 2 generations on269descendants
  • K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…Intuitive Surgical, Inc. · 2002 · 3 generations on260descendants
  • K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · 3 generations on260descendants
  • K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and Endoscopic…Intuitive Surgical, Inc. · 2004 · 3 generations on258descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K930667Reusable Laparoscopic InstrumentsSnowden-Pencer1994—
+1K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer1996—
+2K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic…Intuitive Surgical, Inc.20003
+3K022574Intuitive Surgical Endoscopic Instrument Control System & Endoscopic…Intuitive Surgical, Inc.2002—
+3K021036Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc.200218
+3K040237Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199810
200010
200110
200250
200440
200550
200630
200860
200930
201031
201190
201250
201370
2014120
201560
2016120
2017150
2018180
2019120
2020190
2021170
2022180
2023191
2024220
2025310
2026230
FIG. 1 — Lineage of K930667, 1994–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have 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
Get a 510(k) Report

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? (279)

See all 279

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port…Snowden-Pencer1996273
K092684Laparoscopic Retractors Class ICardinal Health, Inc.20102
K151036Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic InstrumentsCarefusion 2200, Inc.20160
K110257Diamond-Flex (R) GraspersCarefusion 2200, Inc.20110

Has anything in its family been recalled? (2 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 13, 2023Class IIZ-2428-2023Nonconforming Material/ComponentSpecific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Jul 13, 2023Class IIZ-2422-2023Nonconforming Material/ComponentSpecific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Jul 13, 2023Class IIZ-2429-2023Nonconforming Material/ComponentSpecific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Jul 13, 2023Class IIZ-2415-2023Nonconforming Material/ComponentSpecific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Jul 13, 2023Class IIZ-2427-2023Nonconforming Material/ComponentSpecific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Jul 13, 2023Class IIZ-2425-2023Nonconforming Material/ComponentSpecific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Jul 13, 2023Class IIZ-2426-2023Nonconforming Material/ComponentSpecific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Jul 13, 2023Class IIZ-2419-2023Nonconforming Material/ComponentSpecific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Jul 13, 2023Class IIZ-2420-2023Nonconforming Material/ComponentSpecific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Jul 13, 2023Class IIZ-2418-2023Nonconforming Material/ComponentSpecific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Jul 13, 2023Class IIZ-2424-2023Nonconforming Material/ComponentSpecific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Jul 13, 2023Class IIZ-2423-2023Nonconforming Material/ComponentSpecific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Jul 13, 2023Class IIZ-2416-2023Nonconforming Material/ComponentSpecific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Jul 13, 2023Class IIZ-2421-2023Nonconforming Material/ComponentSpecific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Jul 13, 2023Class IIZ-2417-2023Nonconforming Material/ComponentSpecific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.

The 5 latest of 15 recalls; the web page lists all.

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.

  • K092684Laparoscopic RetractorsCardinal Health, Inc. · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
  • 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, K960400 (Snowden-Pencer, 1996) has gone furthest, with 273 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 Snowden-Pencer

10 FDA decisions under this applicant name. See the company

  • K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts)Snowden-Pencer · 1996
  • K930666Reusable Laparoscopic Instruments W/ ElectrocauterySnowden-Pencer · 1994
  • K924148Diamond-Sharp (R) TrocarsSnowden-Pencer · 1994
  • K924149Endo I/a ProbeSnowden-Pencer · 1993
  • K920985Snowden-Pencer Irrigation PumpSnowden-Pencer · 1992

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/K930667 · printed Nov 6, 2026

Cite this page

510(k) Report. “K930667: Reusable Laparoscopic Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K930667

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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