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Acecut Sutomatic Biopsy System

by Meadox Surgimed, Inc.

510(k) K930201

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 NumberK930201 Date9 Jun 1993ClearedStatusActive

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  • Withdrawn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
KNW
Device Class
Class II
Regulation
21 CFR Part 876.1075
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 ACECUT SUTOMATIC BIOPSY SYSTEM is a single-use sterilized biopsy needle used to insert into the human body to collect soft tissue for the purpose of examination, treatment, or diagnosis. It is designed for obtaining tissue samples in clinical settings.

The device is supplied sterile and intended for single-use only. It received FDA 510(k) clearance (K930201) on June 9, 1993, and was found substantially equivalent to a predicate device. The product code is KNW, and it was reviewed by the Gastroenterology-Urology advisory committee.

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Questions

AI-generated answers, 23 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 ACECUT SUTOMATIC BIOPSY SYSTEM used for?

    The ACECUT SUTOMATIC BIOPSY SYSTEM is used to insert into the human body to collect soft tissue samples for examination, treatment, or diagnosis. It is designed for obtaining tissue samples in clinical settings, as stated in the device description.

  • Is the ACECUT SUTOMATIC BIOPSY SYSTEM sterile and single-use?

    Yes, the device is supplied sterile and intended for single-use only. This is explicitly stated in the description, confirming it is sterilized and not designed for reuse.

  • What regulatory clearance does the ACECUT SUTOMATIC BIOPSY SYSTEM have?

    The device received FDA 510(k) clearance under K930201 on June 9, 1993, and was found substantially equivalent to a predicate device. This information is directly from the authorizations and specifications sections.

  • What is the product code and advisory committee for the ACECUT SUTOMATIC BIOPSY SYSTEM?

    The product code is KNW, and it was reviewed by the Gastroenterology-Urology advisory committee (GU). These details are listed in the specifications under product_code and review_advisory_committee.