510(k) · Cleared

Cleared

Pajunk Modular Handle Instruments

K033249510(k) TraditionalCleared Mar 5, 2004150-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

Pajunk GmbH · GCJ Laparoscope, General & Plastic Surgery

Cleared on Mar 5, 2004 as substantially equivalent to K935270 (Richard Wolf Medical Instruments Corp., 1994) after a 150-day review. Its family tree reaches back 1 generation to 1994. 14 later devices descend from it.

Decided: Mar 5, 2004
Review: 150 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K935270 (1994). 14 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK935270 Modular Forcep and Scissor SystemRichard Wolf Medical Instruments Corp. · 1994
This deviceK033249 Pajunk Modular Handle InstrumentsPajunk GmbH · 2004
Descendant · cites it directly · 4 of its ownK102921 Endoscopic Monopolar Instruments and AccessoriesBema-GmbH & Co. KG · 2011
Descendant · cites it directly · 3 of its ownK053282 Adaptable Monopolar Electrodes with Ceramic TipPajunk GmbH · 2005
Descendant · cites it directly · 2 of its ownK062047 Adaptable Monopolar Adaptable and/or Retractable ElectrodesPAJUNK GmbH Medizintechnologie · 2006
Descendant · cites it directly · 2 of its ownK062072 Pajunks Disposable Inserts for Handle Instruments and HF ElectrodesPAJUNK GmbH Medizintechnologie · 2006
Descendant · 2 generations on · 1 of its ownK171825 Disposable Endoscopic Surgical Instrument, Reusable Endoscopic…Hunan Handlike Minimally Invasive Surgery Co., Ltd. · 2018

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2005high 3 (2019) · low 0 (2009)2026

Most influential descendants

Showing 5 of 14 · See all

K102921Endoscopic Monopolar Instruments and AccessoriesBema-GmbH & Co. KG · 2011 · cites it directly4descendants
K053282Adaptable Monopolar Electrodes with Ceramic TipPajunk GmbH · 2005 · cites it directly3descendants
K062047Adaptable Monopolar Adaptable and/or Retractable ElectrodesPAJUNK GmbH Medizintechnologie · 2006 · cites it directly2descendants
K062072Pajunks Disposable Inserts for Handle Instruments and HF ElectrodesPAJUNK GmbH Medizintechnologie · 2006 · cites it directly2descendants
K171825Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical InstrumentHunan Handlike Minimally Invasive Surgery Co., Ltd. · 2018 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K935270	Modular Forcep and Scissor System	Richard Wolf Medical Instruments Corp.	1994	—
0 (this device)	K033249	Pajunk Modular Handle Instruments	Pajunk GmbH	2004	—
+1	K102921	Endoscopic Monopolar Instruments and Accessories	Bema-GmbH & Co. KG	2011	—
+1	K053282	Adaptable Monopolar Electrodes with Ceramic Tip	Pajunk GmbH	2005	—
+1	K062047	Adaptable Monopolar Adaptable and/or Retractable Electrodes	PAJUNK GmbH Medizintechnologie	2006	—
+1	K062072	Pajunks Disposable Inserts for Handle Instruments and HF Electrodes	PAJUNK GmbH Medizintechnologie	2006	—
+2	K171825	Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical…	Hunan Handlike Minimally Invasive Surgery Co., Ltd.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	2	0
2007	1	0
2008	1	0
2011	1	0
2015	1	0
2017	1	0
2018	1	0
2019	3	0
2021	1	0
2022	1	0

FIG. 1 — Lineage of K033249, 1994–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K935270	Modular Forcep and Scissor System Summary page 1 …antial Equivalence: The PAJUNK Modular Handle Instruments are substantially equivalent to the Richard Wolf Medical, Modular Forcep and Scissor System, K935270 in design, materials, methods of construction and intended use. The intended use of the devices to which we claim su…	Richard Wolf Medical Instruments Corp.	1994	—

Also cleared against K935270: 1 other device →

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K102921	Endoscopic Monopolar Instruments and Accessories	Bema-GmbH & Co. KG	2011	4
K053282	Adaptable Monopolar Electrodes with Ceramic Tip	Pajunk GmbH	2005	3
K062047	Adaptable Monopolar Adaptable and/or Retractable Electrodes	PAJUNK GmbH Medizintechnologie	2006	2
K062072	Pajunks Disposable Inserts for Handle Instruments and HF Electrodes	PAJUNK GmbH Medizintechnologie	2006	2
K072715	Realhand High Dexterity Instruments	Novare Surgical Systems, Inc.	2007	1

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?

Its one ancestor has no recall.
Of its descendants, K102921 (Bema-GmbH & Co. KG, 2011) has gone furthest, with 4 descendants of its own.
1 other device also cites its predicate K935270.

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

2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007high 122 (2010) · low 42 (2007)2026

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

Recalls per year · GCJ

5in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	18	42	12	1,639
2008	19	73	16	1,319
2009	21	85	6	1,995
2010	24	122	30	2,657
2011	15	113	9	2,133
2012	17	88	1	1,526
2013	15	93	7 (1)	1,565
2014	19	90	2	1,714
2015	26	76	0	1,710
2016	27	99	5	2,080
2017	20	77	1	3,468
2018	21	88	1	2,562
2019	15	60	0	2,578
2020	28	61	0	2,618
2021	18	116	0	3,431
2022	20	103	1	3,945
2023	31	109	1	6,002
2024	29	90	0	6,047
2025	21	108	5	5,860
2026	26	122	1	—

What is it indicated for?

Instruments insulated for optional monopolar coagulation which enable a surgeon to grasp, manipulate, dissect, retrieve, biopsy, cut or coagulate internal tissue or organs while performing laparoscopic procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033249 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033249: Pajunk Modular Handle Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033249

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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