510(k) · Cleared

Recalled · 2010

Shaw II Hemostatic Surgery System

K902307510(k) TraditionalCleared Aug 17, 199087-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

Hemostatic Surgery Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Aug 17, 1990 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 226 later devices descend from it. It has been recalled 2 times.

Decided: Aug 17, 1990
Review: 87 days
Class: Class II
Product code: GEI
Recalls: 2
Predicates: 0

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

This deviceK902307 Shaw II Hemostatic Surgery SystemHemostatic Surgery Corp. · 1990
Descendant · cites it directly · 222 of its ownK993714 Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000
Descendant · 2 generations on · 117 of its ownK011716 The Uni-Clip StapleNew Deal, S.A. · 2001 · Recalled
Descendant · 2 generations on · 114 of its ownK070031 Memometal Memory StaplesMemometal Technologies · 2007
Descendant · 3 generations on · 103 of its ownK061594 Large Uni-Clip StapleNew Deal, S.A. · 2006
Descendant · 4 generations on · 102 of its ownK070447 Newdeal Compression PlateNewdeal Sas · 2007 · Recalled

Showing 5 of 226 descendants. See all descendants

Descendants cleared per year

1999high 24 (2023) · low 0 (2003)2026

Most influential descendants

Showing 5 of 226 · See all

K993714Memograph Staple, Warm SystemBiomedical Ent., Inc. · 2000 · cites it directly222descendants
K011716The Uni-Clip StapleNew Deal, S.A. · 2001 · 2 generations on117descendants
K070031Memometal Memory StaplesMemometal Technologies · 2007 · 2 generations on114descendants
K061594Large Uni-Clip StapleNew Deal, S.A. · 2006 · 3 generations on103descendants
K070447Newdeal Compression PlateNewdeal Sas · 2007 · 4 generations on102descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K902307	Shaw II Hemostatic Surgery System	Hemostatic Surgery Corp.	1990	—
+1	K993714	Memograph Staple, Warm System	Biomedical Ent., Inc.	2000	—
+2	K011716	The Uni-Clip Staple	New Deal, S.A.	2001	1
+2	K070031	Memometal Memory Staples	Memometal Technologies	2007	—
+3	K061594	Large Uni-Clip Staple	New Deal, S.A.	2006	—
+4	K070447	Newdeal Compression Plate	Newdeal Sas	2007	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	2	0
2000	2	0
2001	1	0
2002	3	0
2005	1	0
2006	1	0
2007	4	0
2009	1	0
2011	1	0
2012	5	0
2013	8	0
2014	15	0
2015	16	0
2016	10	0
2017	22	0
2018	13	0
2019	11	0
2020	19	0
2021	13	0
2022	15	0
2023	24	0
2024	16	0
2025	10	0
2026	13	0

FIG. 1 — Lineage of K902307, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (226)

See all 226

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

Number	Device	Applicant	Decided	Descendants
K993714	Memograph Staple, Warm System	Biomedical Ent., Inc.	2000	222
K990728	Thermal Cautery Device, Forceps	Starion Instruments	1999	2

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 27, 2010	Not classified	Z-2595-2010	Other	Lack of sterility assurance
Jul 27, 2010	Not classified	Z-2596-2010	Other	Lack of sterility assurance

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K993714 (Biomedical Ent., Inc., 2000) has gone furthest, with 222 descendants of its own.

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	—

https://510kreport.com/device/K902307 · printed Nov 6, 2026

Cite this page

510(k) Report. “K902307: Shaw II Hemostatic Surgery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902307

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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