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Moss Steel Breakaway Introducer

by Harry A. Schlakman

510(k) K945480

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK945480 Date28 Aug 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Moss(R) Steel Breakaway(R) Introducer
510(k) Number
FDA Product Code
KOB
Device Class
Class II
Regulation
21 CFR Part 876.5090
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Moss Steel Breakaway Introducer is a suprapubic catheter and accessory device. It is designed to facilitate clinical procedures within the fields of gastroenterology and urology.

This device is regulated under FDA 510(k) clearance K945480. It is classified as a class 2 medical device under regulation number 876.5090.

Other devices from Harry A. Schlakman

Questions

AI-generated answers, 27 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 primary clinical use of the Moss Steel Breakaway Introducer?

    This device is designed to function as a suprapubic catheter and accessory, specifically intended to facilitate clinical procedures within the fields of gastroenterology and urology.

  • What is the regulatory status of this device?

    The Moss Steel Breakaway Introducer is a class 2 medical device regulated under FDA 510(k) clearance number K945480, which indicates it has been found substantially equivalent to legally marketed predicate devices.

  • Which medical specialty committee oversees this device?

    This device is overseen by the Gastroenterology and Urology advisory committee, as it is classified under regulation number 876.5090 for suprapubic catheters and their associated accessories.