# K150067: OTSC Proctology

- Pathway: 510(k) (Traditional)
- Applicant: Ovesco Endoscopy AG
- Decided: Sep 16, 2015 after 246 days
- Product code: PKL (Hemostatic Metal Clip For The Gi Tract)
- Device class: 2
- Regulation: 21 CFR 876.4400
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The OTSC Proctology instrument is indicated for compression of tissue in the anal canal and rectum, for treating wall lesions or for haemostasis other than hemorrhoids in proctology. The OTSC Proctology clip is indicated for placement within the anal canal and rectum for the purpose of treating mucosal/submucosal defects < 3 cm.

Source page: https://510kreport.com/device/K150067
Methodology: https://510kreport.com/methodology