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Flexible Biopsy Cup Forceps

by Surgical Technologies, Inc.

510(k) K941158

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 NumberK941158 Date28 Apr 1994ClearedStatusActive

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  • Withdrawn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
EOQ
Device Class
Class II
Regulation
21 CFR Part 874.4680
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 5 Oct 2026

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

The Flexible Biopsy Cup Forceps are a medical instrument designed for obtaining tissue samples. This device is used to collect biopsies from various anatomical sites.

These forceps are constructed from high-grade materials, allowing for repeated use and sterilization. The autoclavable design ensures optimal sterilization for infection control, and the device has received FDA 510(k) clearance under K941158.

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Questions

AI-generated answers, 5 Oct 2026

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

  • What are the Flexible Biopsy Cup Forceps used for?

    The Flexible Biopsy Cup Forceps are designed for obtaining tissue samples from various anatomical sites during medical procedures.

  • Are the Flexible Biopsy Cup Forceps reusable?

    Yes, these forceps are designed for repeated use. They are constructed from high-grade materials and are autoclavable, allowing for optimal sterilization between uses to ensure infection control.

  • How are the Flexible Biopsy Cup Forceps sterilized?

    The Flexible Biopsy Cup Forceps are sterilized through autoclaving. Their design and material construction allow them to withstand the high temperatures and pressures of an autoclave, ensuring they are free from contaminants for safe use.

  • What is the regulatory status of these biopsy forceps?

    The Flexible Biopsy Cup Forceps have received FDA 510(k) clearance under K941158, indicating they have been found substantially equivalent to a predicate device.