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Radius Pull Percutaneous Endoscopic Gastrostomy Kit

by Radius Intl., Inc.

510(k) K972025

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

29 closed

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 · Traditional NumberK972025 Date23 Jan 1998ClearedStatusActive

Recalls

29 recalls · FDA

  • 27 recalls, same reason

    • Terminated Z-2191-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2179-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2196-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2194-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2201-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2197-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2182-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2199-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2189-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2198-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2183-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2206-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2205-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2203-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2186-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2185-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2192-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2184-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2204-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2200-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2195-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2190-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2207-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2202-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2181-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2180-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2193-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008

    Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retrieval of the remaining piece.

  • 2 recalls, same reason

    • Terminated Z-2188-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008
    • Terminated Z-2187-2009 FDA Unclassified (pre-2012) initiated 4 Dec 2008

    The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retrieval of the remaining piece.

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
KNT
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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