# K973232: Olympus Subfascial Endoscopic Perforating Vein Surgery (Seps) System, Its Associated Accessories and Ancillary Equipment

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Nov 21, 1997 after 85 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K950076 (1995). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963184: Olympus Subcutaneous Endoscopy System, Olympus America, Inc. (1996) Summary page 1.
- K950076: Laparoscope, Olympus America, Inc. (1995) Summary page 1.
- K950103: Laparoscope, Hand Instruments, Olympus America, Inc. (1995) Summary page 1.
- K951855: Ultrathin Ureteroscopes, Olympus America, Inc. (1995) Summary page 1.
- K944072: Olympus Nasal and Sinus Endoscopes, Olympus America, Inc. (1995) Summary page 1.
- K960903: Karl Storz Inst. for Endoscopic Selective Perf. Vein Discission & Paratibial Fasciotomy, KARL STORZ Endoscopy-America, Inc. (1996) Summary page 1.
- K964258: Instruments for Endoscopic Subfascial Discision of Perforating Vins Esdp, Model 8781, Richard Wolf Medical Instruments Corp. (1997) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K973232
Methodology: https://510kreport.com/methodology