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Schuster Disposable Balloon Probe

by Sandhill Scientific, Inc.

510(k) K931175

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK931175 Date1 Apr 1994ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0359-06 FDA Unclassified (pre-2012) initiated 13 Dec 2005

    Labeling does not indicate that the product contains latex.

    • Terminated Z-0356-06 FDA Unclassified (pre-2012) initiated 13 Dec 2005

    The product is mislabeled. The labeling on the front of the packaging states that product contains latex. However, the back of the package contains a latex- free symbol.

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  • Withdrawn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
FAP
Device Class
Class II
Regulation
21 CFR Part 876.1620
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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