# K070924: Flexguard

- Pathway: 510(k) (Traditional)
- Applicant: Allmed Systems, Inc.
- Decided: Jun 21, 2007 after 79 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- 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) Cook - Laser Ureteral Catheter: named in the summary without a submission number

## Indications for use
The FlexGuard Family of sheath's are intended for fiber use in surgical procedures using flexible scopes and other approved flexible or rigid optic delivery devices, to protect the working channel from damage when a laser fiber is introduced and also to provide irrigation to the surgical site when used for incision, excision, ablation, vaporization and coagulation of soft tissue with any approved laser with a wavelength from 532nm to 2100nm in medical specialties including: Urology, Gasteroenterology, Thoracic, Head and Neck, Pulmonary, Gynecology, ENT and General Surgery

Source page: https://510kreport.com/device/K070924
Methodology: https://510kreport.com/methodology