# K960068: SH-1 Surgical Holder for Telescope

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: May 5, 1997 after 486 days
- Product code: OCV (Endoscope Holder)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Aesculap Scope Holder: named in the summary without a submission number
- (no number) Andronic Scope Holder: named in the summary without a submission number
- (no number) Automated Medical Products Scope Holder: named in the summary without a submission number
- (no number) Codman Scope Holder: named in the summary without a submission number
- (no number) Computer Motion Inc. Scope Holder: named in the summary without a submission number
- (no number) Leonard Medical Scope Holder: named in the summary without a submission number
- (no number) Mediflex Scope Holder: named in the summary without a submission number
- (no number) Thompson Medical Products Scope Holder: named in the summary without a submission number

## Indications for use
The Olympus SH-1 Surgical Holder for Telescope can be utilized for the manipulation and positioning of a telescope during laparoscopic procedures.

Source page: https://510kreport.com/device/K960068
Methodology: https://510kreport.com/methodology