# K061663: Endomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for Otolaryngoscopes and Bronchoscopes

- Pathway: 510(k) (Traditional)
- Applicant: Rtc Inc.-Memcath Technologies, LLC
- Decided: Sep 6, 2006 after 93 days
- Product code: EOB (Nasopharyngoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K921244 (1992). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000767: Memcath Urology Introducer Sheath, Model 201, Memcath Technologies, LLC (2000) Summary page 1.
- K042531: Updated Slip Urology Introducer Sheath, Percutaneous Systems, Incorporated (2005) Summary page 1.
- K990354: Endosheath, Vision-Sciences, Inc. (1999) Summary page 1.
- K021344: B-F200 Bronchoscope with BSS-F21 Endosheath System, Vision-Sciences, Inc. (2002) Summary page 1.
- K040215: Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath System, Vision-Sciences, Inc. (2004) Summary page 1.
- K031786: Tne-2000 Esophagoscope with Ecs-D Endosheath System, Vision-Sciences, Inc. (2003) Summary page 1.
- K963344: Disposable SS-F32 Endosheath for Use with the S-F100 Flexible Fiberoptic Sigmoidoscope, Vision-Sciences, Inc. (1996) Summary page 1.

## Indications for use
The EndoMedical Technologies Quik-Cover flexible endoscope barrier sheath provides a sterile, disposable protective covering for endoscopes used during examination of the upper airway, vocal chords, nasal passages, esophagus and pulmonary structures.

Source page: https://510kreport.com/device/K061663
Methodology: https://510kreport.com/methodology