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Model 8800 Aspirator

by Medical Specifics, Inc.

510(k) K963775

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 NumberK963775 Date26 Mar 1997ClearedStatusActive

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  • Withdrawn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
BTA
Device Class
Class II
Regulation
21 CFR Part 878.4780
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Model 8800 Aspirator is a portable, AC-powered or compressed air-powered device designed to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. It may be used during surgery in the operating room or at the patient's bedside and may include a microbial filter.

This device is supplied by Medical Specifics, Inc. and is classified as a Pump, Portable, Aspiration (manual or powered) with product code BTA. It is a Class II device under special controls and received FDA 510(k) clearance on March 26, 1997. The device is intended for use in general and plastic surgery settings.

Questions

AI-generated answers, 26 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 Model 8800 Aspirator used for?

    This device is designed to remove infectious materials from wounds or fluids from a patient's airway and respiratory support system.

  • How is the Model 8800 Aspirator powered?

    It is a portable device that can be powered by an AC outlet or by compressed air.

  • Where can the Model 8800 Aspirator be used?

    It may be used during surgery in the operating room or at the patient's bedside.

  • What is the regulatory status of the Model 8800 Aspirator?

    It is a Class II device under special controls and received FDA 510(k) clearance on March 26, 1997.