510(k) · Cleared

Cleared

Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical Instruments and Accessories

K031869510(k) TraditionalCleared Dec 24, 2003190-day reviewClass II21 CFR 878.4400

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

Surgical Instruments Service and Savings, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Dec 24, 2003 as substantially equivalent to K984240 (Ethicon Endo-Surgery, Inc., 1999) and 5 other predicates after a 190-day review. Its family tree reaches back 3 generations to 1991.

Decided: Dec 24, 2003
Review: 190 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 6

Its longest line of descent runs back 3 generations to K910831 (1991). 9 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK910831 Endopath Surgical InstrumentsSymbiosis Corp. · 1991
2 generations backK984240 Endopath Endoscopic InstrumentsEthicon Endo-Surgery, Inc. · 1999 · Recalled
1 generation backK012625 Reprocessed Unipolar Laparoscopic/Endoscopic InstrumentsAlliance Medical Corp. · 2001
This deviceK031869 Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical Instruments…Surgical Instruments Service and Savings, Inc. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K910831	Endopath Surgical Instruments	Symbiosis Corp.	1991	—
−2	K984240	Endopath Endoscopic Instruments	Ethicon Endo-Surgery, Inc.	1999	1
−1	K012625	Reprocessed Unipolar Laparoscopic/Endoscopic Instruments	Alliance Medical Corp.	2001	—
0 (this device)	K031869	Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical Instruments and…	Surgical Instruments Service and Savings, Inc.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1994	2	0
1995	1	0
2001	2	0

FIG. 1 — Lineage of K031869, 1991–2003Source: 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

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What was it cleared against? (6)

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 …calI instruments manul'actured bN: Ethicon t .S.Surgical These devices arc legal 'ly marketed and distributed pursuant to 5 10(k)'s K984240, K951589, and K934784 and the counterpart devices friom the original manufacturers. Ihev are also simil…	Ethicon Endo-Surgery, Inc.	1999	1
*	K951589	Manual Surgical Insrument Summary page 1 …l'actured bN: Ethicon t .S.Surgical These devices arc legal 'ly marketed and distributed pursuant to 5 10(k)'s K984240, K951589, and K934784 and the counterpart devices friom the original manufacturers. Ihev are also similar to the reprocessed…	United States Surgical, A Division of Tyco Healthc	1995	—
*	K934784	Endopath Endoscopic Electrosurgical Forceps with Cutting Feature Summary page 1 …Ethicon t .S.Surgical These devices arc legal 'ly marketed and distributed pursuant to 5 10(k)'s K984240, K951589, and K934784 and the counterpart devices friom the original manufacturers. Ihev are also similar to the reprocessed elec'trosurg…	ETHICON, Inc.	1994	—
*	K012625	Reprocessed Unipolar Laparoscopic/Endoscopic Instruments Summary page 1 …he reprocessed elec'trosurgical instruments and accessories reprocessed by Alliance Corporation and legally marketed and distributed pursuant to, K01 2625. Likewise, StcrilMed., Inc. Reprocessed Lparosc/opic Electric histroum/ents: - 510(k) KO 125t8: and Vanguard Medical…	Alliance Medical Corp.	2001	—
*	K012598	Reprocessed Laparoscopic Electric Instuments Our OCR of the scanned summary read K012518, FDA’s number for Trace Scientific Alkaline Phosphatase, Two Part Liquid… (Thermo Dma, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SterilMed, Inc. Reprocessed Laparoscopic Electric Instruments”.	Sterilmed, Inc.	2001	1
*	K012700	Vanguard Reprocessed Endoscopic Instruments	Vanguard Medical Concepts, Inc.	2001	—

Also cleared against K984240: 12 other devices →

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?

The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
2 of the 9 ancestors have a recall of any class.
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 SISS Inc. (d.b.a. MediSISS) Reprocessed electrosurgical instruments have applications in a variety of minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, and/or to facilitate coagulation, transection, resection, mobilization, and dissections of tissue.

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/K031869 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031869: Siss Inc. (D.B.a. Medisiss) Reprocessed Electrosurgical Instruments and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031869

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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