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Karl Storz Pediatric Pyloric Spreader, Pylorotome, Endotome

by Karl Storz Endoscopy-America, Inc.

510(k) K951252

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 · Traditional NumberK951252 Date25 Apr 1995ClearedStatusActive

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  • Withdrawn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
GCJ
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Karl Storz Pediatric Pyloric Spreader, Pylorotome, Endotome is a medical device designed for use in pyloromyotomy procedures. It features a slim design with a double action mechanism and angled jaws that are serrated on the outside. The instrument can be used without a trocar and is specifically designed for pediatric applications.

This device is supplied as part of a complete instrument set for pyloromyotomy procedures. It is intended for use in the treatment of pyloric stenosis in infants. The device has received FDA 510(k) clearance with number K951252 and is classified under product code GCJ.

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Questions

AI-generated answers, 22 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 Karl Storz Pediatric Pyloric Spreader used for?

    The Karl Storz Pediatric Pyloric Spreader is designed specifically for pyloromyotomy procedures to treat pyloric stenosis in infants. It features a slim design with double-action mechanism and angled serrated jaws that can be used without a trocar.

  • How is the Pediatric Pyloric Spreader supplied?

    This device is supplied as part of a complete instrument set specifically for pyloromyotomy procedures. The set includes all necessary components for performing the pediatric pyloric stenosis treatment.

  • What is the regulatory status of this device?

    The Karl Storz Pediatric Pyloric Spreader has received FDA 510(k) clearance with number K951252. It is classified under product code GCJ and was determined to be substantially equivalent through the traditional clearance process.

  • Is this device reusable or single-use?

    The device data does not specify whether the Pediatric Pyloric Spreader is designed for single-use or multiple uses. For proper handling and sterilization procedures, please refer to the manufacturer's instructions included with the instrument set.