# K964258: Instruments for Endoscopic Subfascial Discision of Perforating Vins Esdp, Model 8781

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Jan 16, 1997 after 83 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Richard Wolf model 8981.01: named in the summary without a submission number
- (no number) Richard Wolf model 8449.20: named in the summary without a submission number
- (no number) Richard Wolf model 8960.01: named in the summary without a submission number
- (no number) Richard Wolf model 8960.02: named in the summary without a submission number
- (no number) Richard Wolf model 8960.03: named in the summary without a submission number
- (no number) Richard Wolf model 4937D: named in the summary without a submission number
- (no number) Richard Wolf model 8383.753: named in the summary without a submission number
- (no number) Richard Wolf model 8267.10: named in the summary without a submission number

## Most influential descendants
- K973943: Instruments for Endoscopic Subfascial Harvesting of Veins (Eshv), Instruments for Endoscopic Subfascial Discision of Per (1998), 0 descendants of its own
- K973232: Olympus Subfascial Endoscopic Perforating Vein Surgery (Seps) System, Its Associated Accessories and Ancillary Equipment (1997), 0 descendants of its own

## Indications for use
The “ESDP” instrument set is used for minimally invasive visualization and diagnostic and therapeutic procedures of superficial veins in the lower extremities, e.g. the saphenous vein. The intervention takes place under sterile conditions.

Source page: https://510kreport.com/device/K964258
Methodology: https://510kreport.com/methodology