510(k) · Cleared

Cleared

Olympus Subfascial Endoscopic Perforating Vein Surgery (Seps) System, Its Associated Accessories and Ancillary Equipment

K973232510(k) TraditionalCleared Nov 21, 199785-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

Olympus Winter & Ibe GmbH · GCJ Laparoscope, General & Plastic Surgery

Cleared on Nov 21, 1997 as substantially equivalent to K963184 (Olympus America, Inc., 1996) and 6 other predicates after an 85-day review. Its family tree reaches back 2 generations to 1995.

Decided: Nov 21, 1997
Review: 85 days
Class: Class II
Product code: GCJ
Recalls: None
Predicates: 7

Its longest line of descent runs back 2 generations to K950076 (1995). 8 ancestors in all, the oldest K944072 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK950076 LaparoscopeOlympus America, Inc. · 1995
1 generation backK963184 Olympus Subcutaneous Endoscopy SystemOlympus America, Inc. · 1996
This deviceK973232 Olympus Subfascial Endoscopic Perforating Vein Surgery (Seps)…Olympus Winter & Ibe GmbH · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K950076	Laparoscope	Olympus America, Inc.	1995	—
−1	K963184	Olympus Subcutaneous Endoscopy System	Olympus America, Inc.	1996	—
0 (this device)	K973232	Olympus Subfascial Endoscopic Perforating Vein Surgery (Seps) System, Its…	Olympus Winter & Ibe GmbH	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	3	0
1996	2	0
1997	1	0

FIG. 1 — Lineage of K973232, 1995–1997Source: 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? (7)

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
*	K963184	Olympus Subcutaneous Endoscopy System Summary page 1 …Olympus SEPS System Subfascial Endoscopic Perforating Vein Surgery System Class I1, 21 CFR 876.1500 Endoscope and Accessories. Olympus Subcutaneous Endoscopy System (K963184) Endoscopic Plastic/Reconstructive and Aesthetic Surgery Endoscopes (K950076) Endoscopic Plastic/Reconstructive and Aesthetic S…	Olympus America, Inc.	1996	—
*	K950076	Laparoscope Summary page 1 …lass I1, 21 CFR 876.1500 Endoscope and Accessories. Olympus Subcutaneous Endoscopy System (K963184) Endoscopic Plastic/Reconstructive and Aesthetic Surgery Endoscopes (K950076) Endoscopic Plastic/Reconstructive and Aesthetic Surgery Hand Instruments (K950103) Olympus Ultrathin Ureteroscope (K951855) O…	Olympus America, Inc.	1995	—
*	K950103	Laparoscope, Hand Instruments Summary page 1 …System (K963184) Endoscopic Plastic/Reconstructive and Aesthetic Surgery Endoscopes (K950076) Endoscopic Plastic/Reconstructive and Aesthetic Surgery Hand Instruments (K950103) Olympus Ultrathin Ureteroscope (K951855) Olympus Nasal & Sinus Endoscopes (K944072) KSEA Instrument Set for Endoscopic Surger…	Olympus America, Inc.	1995	—
*	K951855	Ultrathin Ureteroscopes Summary page 1 …structive and Aesthetic Surgery Endoscopes (K950076) Endoscopic Plastic/Reconstructive and Aesthetic Surgery Hand Instruments (K950103) Olympus Ultrathin Ureteroscope (K951855) Olympus Nasal & Sinus Endoscopes (K944072) KSEA Instrument Set for Endoscopic Surgery of Superfacial Veins and Fascia of the l…	Olympus America, Inc.	1995	—
*	K944072	Olympus Nasal and Sinus Endoscopes Summary page 1 …K950076) Endoscopic Plastic/Reconstructive and Aesthetic Surgery Hand Instruments (K950103) Olympus Ultrathin Ureteroscope (K951855) Olympus Nasal & Sinus Endoscopes (K944072) KSEA Instrument Set for Endoscopic Surgery of Superfacial Veins and Fascia of the lower Extremitigs' (K960903) Richard Wolf In…	Olympus America, Inc.	1995	—
*	K960903	Karl Storz Inst. for Endoscopic Selective Perf. Vein Discission & Paratibial Fasciotomy Summary page 1 …Ureteroscope (K951855) Olympus Nasal & Sinus Endoscopes (K944072) KSEA Instrument Set for Endoscopic Surgery of Superfacial Veins and Fascia of the lower Extremitigs' (K960903) Richard Wolf Instruments for Endoscopic Subfascial Discision of Perforating Veins - ESDP (K964258) Mr. Subhash Patel Olympus…	KARL STORZ Endoscopy-America, Inc.	1996	—
*	K964258	Instruments for Endoscopic Subfascial Discision of Perforating Vins Esdp, Model 8781 Summary page 1 …ic Surgery of Superfacial Veins and Fascia of the lower Extremitigs' (K960903) Richard Wolf Instruments for Endoscopic Subfascial Discision of Perforating Veins - ESDP (K964258) Mr. Subhash Patel Olympus America Inc. Endoscope Division Two Corporate Center Drive Melville, New York 11747-3157 (516) 844-…	Richard Wolf Medical Instruments Corp.	1997	—

Also cleared against K963184: 2 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 2 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
None of the 8 ancestors has a recall.
2 other devices also cite its predicate K963184.

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 Olympus SEPS System is designed for subcutaneous endoscopy -- more specifically, for endoscopically gaining access to vessels (arteries, veins, ducts, nerves) in subcutaneous and subfascial surgical planes in the lower extremities for endoscopic observation, diagnosis, and treatment.

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/K973232 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973232: Olympus Subfascial Endoscopic Perforating Vein Surgery (Seps) System, Its Associated Accessories and Ancillary Equipment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973232

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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