510(k) · Cleared

Cleared

Pneumo Dissector Hook

K252957510(k) TraditionalCleared Jan 23, 2026129-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

Ab Medica Sas · GCJ Laparoscope, General & Plastic Surgery

Cleared on Jan 23, 2026 as substantially equivalent to K972647 (Cook Urological, Inc., 1998) and 2 other predicates after a 129-day review. Its family tree reaches back 1 generation to 1992.

Decided: Jan 23, 2026
Review: 129 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K913944 (1992). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK913944 Nezhat/Dorsey Hydro Dissection Pump & AccessoriesAmerican Surgical Instruments Corp. · 1992
This deviceK252957 Pneumo Dissector HookAb Medica Sas · 2026

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K913944	Nezhat/Dorsey Hydro Dissection Pump & Accessories	American Surgical Instruments Corp.	1992	—
0 (this device)	K252957	Pneumo Dissector Hook	Ab Medica Sas	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	1	0

FIG. 1 — Lineage of K252957, 1992–2026Source: 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 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? (3)

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
*	K972647	CO2 Pneumo-Dissector Summary page 5 …and Regulation Primary CO2 Pneumo Dissector Cook Urological Inc K972647 HET, 884.1720 Secondary #1 Nezhat-Dorsey Hydrodissection American Surgical K913944 HET, 884.1720…	Cook Urological, Inc.	1998	—
*	K913944	Nezhat/Dorsey Hydro Dissection Pump & Accessories Summary page 5 …n Primary CO2 Pneumo Dissector Cook Urological Inc K972647 HET, 884.1720 Secondary #1 Nezhat-Dorsey Hydrodissection American Surgical K913944 HET, 884.1720 Instruments Inc Secondary #2 Hydro-Surg…	American Surgical Instruments Corp.	1992	—
*	K961492	Hydro-Surg Laparoscopic Irrigaton Models 0026000. 0026010 Summary page 5 …cal K913944 HET, 884.1720 Instruments Inc Secondary #2 Hydro-Surg Davol / Bard K961492 GCJ, 876.1500 Ab Medica SAS January 22, 2026 Traditional 510(k) for Pneumo Dissect…	Davol Inc., Sub. C. R. Bard, Inc.	1996	2
†	K140101	Abmedica Reusable Laparoscopic Hand Instruments and Trocars	Ab Medica Sas	2014	—

What descends from it?

No later submission names this one as a predicate yet.

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?

1 of the 3 ancestors has a recall of any class.

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. 2026, this device’s year, is highlighted.

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?

The &2ၷ Pneumo-Dissector is used to dissect planes of soft tissue using pressure regulated trigger-controlled pulses of medical grade &2ၷ gas. The device may be used in endoscopic, laparoscopic and open procedures in which gentle blunt dissection of soft tissue planes is desired. Use the product only in accordance with the instructions provided.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K252957 · printed Nov 5, 2026

Cite this page

510(k) Report. “K252957: Pneumo Dissector Hook.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252957

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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