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FDA 510(k)

PREPACELL THIN NEEDLE ASPIRATION TRAY

K-Number: K833719 · 1984-01-25

ApplicantApplied Medical Devices, Inc.
Decision Date1984-01-25
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PREPACELL THIN NEEDLE ASPIRATION TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Devices, Inc.. It received FDA 510(k) clearance on 1984-01-25 under 510(k) number K833719. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREPACELL THIN NEEDLE ASPIRATION TRAY?

PREPACELL THIN NEEDLE ASPIRATION TRAY is a medical device that received FDA 510(k) clearance on 1984-01-25. The listed applicant is Applied Medical Devices, Inc.. The 510(k) number is K833719.

When did PREPACELL THIN NEEDLE ASPIRATION TRAY receive FDA 510(k) clearance?

PREPACELL THIN NEEDLE ASPIRATION TRAY received FDA 510(k) clearance on 1984-01-25, under 510(k) number K833719.

Who is the listed applicant for PREPACELL THIN NEEDLE ASPIRATION TRAY?

The FDA 510(k) record lists Applied Medical Devices, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREPACELL THIN NEEDLE ASPIRATION TRAY?

The FDA product code for PREPACELL THIN NEEDLE ASPIRATION TRAY is KOD.

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Other records listing Applied Medical Devices, Inc. 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.

K843885PERCUTANEOUS ASPIRATION BIOPSY TRAYK843883STERILE PERCUTANEOUS TRANSHEPATIC CHOLANK843884GENERAL UTILITY TRAY SYSTEMK840904ACCU-CULT FECAL OCCULT BLOOD TESTK842591ULTRASOUND PROBE COVERS-STERILEK833720TRANSTHORACIC/TRANSABDOMINAL-TRAY

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Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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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