510(k) · Cleared

Cleared

Dexterity Pneumo Sleeve Set

K962147510(k) TraditionalCleared Jul 9, 199636-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

Medical Creative Technologies, Inc. · GCJ Laparoscope, General & Plastic Surgery

Cleared on Jul 9, 1996 as substantially equivalent to K954824 (Medical Creative Technologies, Inc., 1996) after a 36-day review. Its family tree reaches back 1 generation to 1996. 6 later devices descend from it.

Decided: Jul 9, 1996
Review: 36 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K954824 (1996). 6 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK954824 Protector Retractor & Protector Retractor with DrapeMedical Creative Technologies, Inc. · 1996
This deviceK962147 Dexterity Pneumo Sleeve SetMedical Creative Technologies, Inc. · 1996
Descendant · cites it directly · 5 of its ownK990414 Smith & Nephew Handport SystemSmith & Nephew, Inc. · 1999
Descendant · 2 generations on · 4 of its ownK014047 Applied Gelport Laparoscopic Hand Access DeviceApplied Medical Resources Corp. · 2002
Descendant · 3 generations on · 3 of its ownK090275 Gelport Single Incision Access SystemApplied Medical Resources Corp. · 2009
Descendant · 3 generations on · 0 of its ownK202688 AFS Medical Sterile Single-Use Access Port SystemAfs Medical Co., Ltd. · 2021
Descendant · 4 generations on · 0 of its ownK120898 Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX…Richard Wolf Medical Instruments Corp. · 2012

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1999high 1 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 6 · See all

K990414Smith & Nephew Handport SystemSmith & Nephew, Inc. · 1999 · cites it directly5descendants
K014047Applied Gelport Laparoscopic Hand Access DeviceApplied Medical Resources Corp. · 2002 · 2 generations on4descendants
K090275Gelport Single Incision Access SystemApplied Medical Resources Corp. · 2009 · 3 generations on3descendants
K202688AFS Medical Sterile Single-Use Access Port SystemAfs Medical Co., Ltd. · 2021 · 3 generations on0descendants
K120898Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport Trucar 8850XX…Richard Wolf Medical Instruments Corp. · 2012 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K954824	Protector Retractor & Protector Retractor with Drape	Medical Creative Technologies, Inc.	1996	—
0 (this device)	K962147	Dexterity Pneumo Sleeve Set	Medical Creative Technologies, Inc.	1996	—
+1	K990414	Smith & Nephew Handport System	Smith & Nephew, Inc.	1999	—
+2	K014047	Applied Gelport Laparoscopic Hand Access Device	Applied Medical Resources Corp.	2002	—
+3	K090275	Gelport Single Incision Access System	Applied Medical Resources Corp.	2009	—
+3	K202688	AFS Medical Sterile Single-Use Access Port System	Afs Medical Co., Ltd.	2021	—
+4	K120898	Keyport System, Includes: Keyport Silicone Sealing Insert 8850XXX Keyport…	Richard Wolf Medical Instruments Corp.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2002	1	0
2009	1	0
2010	1	0
2012	1	0
2021	1	0

FIG. 1 — Lineage of K962147, 1996–2021Source: 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

Get a 510(k) Report

What was it cleared against? (2)

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
*	K954824	Protector Retractor & Protector Retractor with Drape Summary page 2 …e Protector® Retractor which is a component of this device is the same device as the Protector® Retractor (second predicate device named above) approved by 510(k) Number K954824. The Dexterity® Pneumo Sleeve is made from the same 3 mil thick plastic film used to make the sleeve of the Protector® Retractor.…	Medical Creative Technologies, Inc.	1996	—
*	—	Trocar/Cannula by Storz Named without a submission number			—

Also cleared against K954824: 3 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K990414	Smith & Nephew Handport System	Smith & Nephew, Inc.	1999	5

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, K990414 (Smith & Nephew, Inc., 1999) has gone furthest, with 5 descendants of its own.
3 other devices also cite its predicate K954824.

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?

The Dexterity® Pneumo Sleeve is intended to provide abdominal access for the surgeon’s hand while preserving pneumoperitoneum during laparoscopic surgery.

The Protector® Retractor is intended to provide incision retraction and to protect it against wound contamination during both laparoscopic and open surgery.

This device allows the surgeon to use his hand while performing corrective surgery in the abdominal cavity under pneumoperitoneum.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K962147 · printed Nov 4, 2026

Cite this page

510(k) Report. “K962147: Dexterity Pneumo Sleeve Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962147

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