510(k) · Cleared

Recalled · 2011

Purewrist Scissors, Model PW1101-01;Purewrist Dissector, Model PW1201-01;Purewrist Hook, Model PW1301-01

K061425510(k) TraditionalCleared Aug 10, 200679-day reviewClass II21 CFR 878.4400Recalls 2

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

Cambridge Endoscopic Devices · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Aug 10, 2006 as substantially equivalent to K984240 (Ethicon Endo-Surgery, Inc., 1999) after a 79-day review. Its family tree reaches back 2 generations to 1991. 14 later devices descend from it. It has been recalled 2 times.

Decided: Aug 10, 2006
Review: 79 days
Class: Class II
Product code: GEI
Recalls: 2
Predicates: 1

Its longest line of descent runs back 2 generations to K910831 (1991). 14 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 2 generations backK910831 Endopath Surgical InstrumentsSymbiosis Corp. · 1991
1 generation backK984240 Endopath Endoscopic InstrumentsEthicon Endo-Surgery, Inc. · 1999 · Recalled
This deviceK061425 Purewrist Scissors, Model PW1101-01;Purewrist Dissector, Model…Cambridge Endoscopic Devices · 2006
Descendant · cites it directly · 8 of its ownK173919 HX DeviceHuman Extension, Ltd. · 2018
Descendant · 2 generations on · 3 of its ownK203603 Monopolar HookHuman Xtensions, Ltd. · 2021
Descendant · cites it directly · 1 of its ownK173405 DiLumen Endolumenal Interventional Scissors (DiLumen Is)Lumendi, LLC · 2018
Descendant · 2 generations on · 0 of its ownK260183 MediBot Needle Driver UnoParallel Robotics, LLC · 2026
Descendant · 2 generations on · 0 of its ownK243968 Revolve Surgical SystemRevolve Surgical, Inc. · 2025

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2008high 3 (2021) · low 0 (2009)2026

Most influential descendants

Showing 5 of 14 · See all

K173919HX DeviceHuman Extension, Ltd. · 2018 · cites it directly8descendants
K203603Monopolar HookHuman Xtensions, Ltd. · 2021 · 2 generations on3descendants
K173405DiLumen Endolumenal Interventional Scissors (DiLumen Is)Lumendi, LLC · 2018 · cites it directly1descendant
K260183MediBot Needle Driver UnoParallel Robotics, LLC · 2026 · 2 generations on0descendants
K243968Revolve Surgical SystemRevolve Surgical, Inc. · 2025 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K910831	Endopath Surgical Instruments	Symbiosis Corp.	1991	—
−1	K984240	Endopath Endoscopic Instruments	Ethicon Endo-Surgery, Inc.	1999	1
0 (this device)	K061425	Purewrist Scissors, Model PW1101-01;Purewrist Dissector, Model…	Cambridge Endoscopic Devices	2006	—
+1	K173919	HX Device	Human Extension, Ltd.	2018	—
+2	K203603	Monopolar Hook	Human Xtensions, Ltd.	2021	—
+1	K173405	DiLumen Endolumenal Interventional Scissors (DiLumen Is)	Lumendi, LLC	2018	—
+2	K260183	MediBot Needle Driver Uno	Parallel Robotics, LLC	2026	—
+2	K243968	Revolve Surgical System	Revolve Surgical, Inc.	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2011	1	0
2018	2	0
2019	1	0
2021	3	0
2023	3	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K061425, 1991–2026Source: 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 GEI? 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 GEI device

#1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

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
*	K984240	Endopath Endoscopic Instruments Summary page 1 …y laparoscopic instruments are substantially equivalent to the Ethicon Endo- Surgery, Inc. ENDOPATH-I Endoscopic Instruments dleared and under K984240. 4. Device Description The pureWrist~m electrocautery laparoscopic instruments are sterile, single use di…	Ethicon Endo-Surgery, Inc.	1999	1

Also cleared against K984240: 12 other devices →

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
K173919	HX Device	Human Extension, Ltd.	2018	8
K173405	DiLumen Endolumenal Interventional Scissors (DiLumen Is)	Lumendi, LLC	2018	1
K191878	DEX Device	Dex Surgical	2021	0
K111412	Surgisteer Scissors, Surgisteer Dissector / Grasper, Surgisteer Hook	Steerable Technologix	2011	0
K072811	Marionette SA, Model 001 001 & 001 002	Kinetic Surgical, LLC	2008	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 20, 2011	Not classified	Z-2743-2011	Process control	PET shrink sleeve insulation material dislodging from the distal tips of Autonomy Laparo-Angle (ALA) Metzenbaum Scissors
May 20, 2011	Not classified	Z-2744-2011	Process control	PET shrink sleeve insulation material dislodging from the distal tips of Autonomy Laparo-Angle (ALA) Metzenbaum Scissors

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
1 of the 2 ancestors has a recall of any class.
Of its descendants, K173919 (Human Extension, Ltd., 2018) has gone furthest, with 8 descendants of its own.
12 other devices also cite its predicate K984240.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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	50	51	21	2,795
2008	61	71	19	2,556
2009	42	130	27	3,591
2010	46	109	51	3,377
2011	35	135	32	4,463
2012	39	133	30	5,216
2013	48	136	13	4,897
2014	49	103	3	4,908
2015	47	123	4	4,936
2016	64	108	3	5,616
2017	52	72	2	6,073
2018	47	93	6	6,545
2019	48	93	5	7,067
2020	59	105	1	6,490
2021	46	146	6	6,354
2022	55	150	49	6,103
2023	65	104	27 (4)	7,176
2024	59	125	22 (10)	7,897
2025	52	113	4	7,592
2026	43	183	8	—

What is it indicated for?

The pureWrist™ electrocautery laparoscopic instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection, and transection of tissue.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061425 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061425: Purewrist Scissors, Model PW1101-01;Purewrist Dissector, Model PW1201-01;Purewrist Hook, Model PW1301-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061425

Report an extraction error

Are you the manufacturer?

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