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Seal Single-Use Biopsy Valve

by Endochoice, Inc. 2 variants

510(k) K161167

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK161167 Date26 May 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OCX
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Seal Single-Use Biopsy Valve is an endoscopic irrigation/suction system designed for use in gastroenterology and urology procedures. It provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the biopsy port during endoscopic procedures.

The device is supplied sterile and intended for single-use only. It is authorized under FDA 510(k) clearance (K161167) and is classified as a Class II medical device under regulation number 876.1500. The valve is used in clinical endoscopic settings to support irrigation and maintain scope pressure while reducing the risk of cross-contamination between patients.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Seal Single-Use Biopsy Valve used for?

    The Seal Single-Use Biopsy Valve is designed for use in gastroenterology and urology endoscopic procedures to provide access for endoscopic device passage and exchange, help maintain insufflation, and minimize leakage of biomaterial from the biopsy port during irrigation and suction.

  • Is the Seal Single-Use Biopsy Valve sterile and intended for single-use or reuse?

    The device is supplied sterile and is intended for single-use only, as stated in its labeling and authorization, to reduce the risk of cross-contamination between patients during endoscopic procedures.

  • What regulatory authorization does the Seal Single-Use Biopsy Valve have?

    The Seal Single-Use Biopsy Valve is authorized under FDA 510(k) clearance (K161167) and is classified as a Class II medical device under regulation number 876.1500, based on its substantial equivalence to a legally marketed predicate device.