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FDA 510(k)

ACKRAD ORAL SUCTION TUBE

K-Number: K854320 · 1986-01-10

ApplicantAckrad Laboratories
Decision Date1986-01-10
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ACKRAD ORAL SUCTION TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Ackrad Laboratories. It received FDA 510(k) clearance on 1986-01-10 under 510(k) number K854320. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACKRAD ORAL SUCTION TUBE?

ACKRAD ORAL SUCTION TUBE is a medical device that received FDA 510(k) clearance on 1986-01-10. The listed applicant is Ackrad Laboratories. The 510(k) number is K854320.

When did ACKRAD ORAL SUCTION TUBE receive FDA 510(k) clearance?

ACKRAD ORAL SUCTION TUBE received FDA 510(k) clearance on 1986-01-10, under 510(k) number K854320.

Who is the listed applicant for ACKRAD ORAL SUCTION TUBE?

The FDA 510(k) record lists Ackrad Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACKRAD ORAL SUCTION TUBE?

The FDA product code for ACKRAD ORAL SUCTION TUBE is BSY.

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Other records listing Ackrad Laboratories as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K021272SIB CATHETER, MODEL 61-7005K020954H/S PROCEDURE TRAY (5F), H/S PROCEDURE TRAY (7F), H/S ELLIPTOSPHERE PROCEDURE TRAY & MULTIPURPOSE PROCEDURE TRAYK020951H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007K970492INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETERK961752H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)K940176ACKRAD IUI SET FOR INTRAUTERINE INSEMINATION

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Related Devices (Code: BSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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