510(k) Report

510(k) · Cleared

Cleared

Modular Forcep and Scissor System

K935270510(k) TraditionalCleared Aug 26, 1994297-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

Richard Wolf Medical Instruments Corp. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Aug 26, 1994 after a 297-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 27 later devices descend from it.

Decided
Aug 26, 1994
Review
297 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
0

27 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2004: 1 descendant cleared2011: 1 descendant cleared2007: 1 descendant cleared2006: 3 descendants cleared2005: 1 descendant cleared1998: 2 descendants cleared2019: 3 descendants cleared2008: 1 descendant cleared2015: 2 descendants cleared2022: 1 descendant cleared2018: 2 descendants cleared2017: 1 descendant cleared2002: 1 descendant cleared2021: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant cleared2014: 1 descendant cleared2012: 1 descendant cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK935270 Modular Forcep and Scissor SystemRichard Wolf Medical Instruments Corp. · 1994
  2. Descendant · cites it directly · 14 of its ownK033249 Pajunk Modular Handle InstrumentsPajunk GmbH · 2004
  3. Descendant · cites it directly · 11 of its ownK973648 Mini Forceps with HF, 3.5MM; Micro Forceps with HF, 2MMRichard Wolf Medical Instruments Corp. · 1997
  4. Descendant · 2 generations on · 10 of its ownK980758 3 MM Selec-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1998
  5. Descendant · 3 generations on · 8 of its ownK014207 Reposable Instrument System, Models MF001-MF083Aesculap, Inc. · 2002
  6. Descendant · 4 generations on · 7 of its ownK063485 Logic Laparoscopic ScissorsSurgical Innovations Plc · 2006

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

1997: 11998: 22002: 12004: 12005: 12006: 32007: 12008: 12009: 12010: 12011: 12012: 12014: 12015: 22017: 12018: 22019: 32021: 12022: 12024: 1
1997high 3 (2006) · low 0 (1999)2026

Most influential descendants

Showing 5 of 27 · See all
  • K033249Pajunk Modular Handle InstrumentsPajunk GmbH · 2004 · cites it directly14descendants
  • K973648Mini Forceps with HF, 3.5MM; Micro Forceps with HF, 2MMRichard Wolf Medical Instruments Corp. · 1997 · cites it directly11descendants
  • K9807583 MM Selec-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1998 · 2 generations on10descendants
  • K014207Reposable Instrument System, Models MF001-MF083Aesculap, Inc. · 2002 · 3 generations on8descendants
  • K063485Logic Laparoscopic ScissorsSurgical Innovations Plc · 2006 · 4 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K935270Modular Forcep and Scissor SystemRichard Wolf Medical Instruments Corp.1994—
+1K033249Pajunk Modular Handle InstrumentsPajunk GmbH2004—
+1K973648Mini Forceps with HF, 3.5MM; Micro Forceps with HF, 2MMRichard Wolf Medical Instruments Corp.1997—
+2K9807583 MM Selec-Tip Laparoscopic ScissorsMicroline Pentax, Inc.1998—
+3K014207Reposable Instrument System, Models MF001-MF083Aesculap, Inc.2002—
+4K063485Logic Laparoscopic ScissorsSurgical Innovations Plc2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199820
200210
200410
200510
200630
200710
200810
200910
201010
201110
201210
201410
201520
201710
201820
201930
202110
202210
202410
FIG. 1 — Lineage of K935270, 1994–2024Source: 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.

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
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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? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K033249Pajunk Modular Handle InstrumentsPajunk GmbH200414
K973648Mini Forceps with HF, 3.5MM; Micro Forceps with HF, 2MMRichard Wolf Medical Instruments Corp.199711

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?

  • Of its descendants, K033249 (Pajunk GmbH, 2004) has gone furthest, with 14 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—
Cite this page

510(k) Report. “K935270: Modular Forcep and Scissor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935270

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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