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FDA 510(k)

SOFT TISSUE BIOPSY DEVICE

K-Number: K882013 · 1988-06-15

ApplicantOcean Medical Products, Ltd.
Decision Date1988-06-15
Product CodeDWO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOFT TISSUE BIOPSY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Ocean Medical Products, Ltd.. It received FDA 510(k) clearance on 1988-06-15 under 510(k) number K882013. The device is classified under product code DWO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFT TISSUE BIOPSY DEVICE?

SOFT TISSUE BIOPSY DEVICE is a medical device that received FDA 510(k) clearance on 1988-06-15. The listed applicant is Ocean Medical Products, Ltd.. The 510(k) number is K882013.

When did SOFT TISSUE BIOPSY DEVICE receive FDA 510(k) clearance?

SOFT TISSUE BIOPSY DEVICE received FDA 510(k) clearance on 1988-06-15, under 510(k) number K882013.

Who is the listed applicant for SOFT TISSUE BIOPSY DEVICE?

The FDA 510(k) record lists Ocean Medical Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOFT TISSUE BIOPSY DEVICE?

The FDA product code for SOFT TISSUE BIOPSY DEVICE is DWO.

Related Clinical Trials

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.

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Other records listing Ocean Medical Products, Ltd. 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.

K870896NOTCH-NEEDLE, WESCOTT STYLEK843719SINGLE WALL INTRODUCER NEEDLEK823693MYELOGRAPHY NEEDLEK823692SPINAL NEEDLEK813462MADAYAG TYPE NEEDLEK813448POTTS-COURNAND STYLE NEEDLE

View all 9 devices →

Related Devices (Code: DWO)

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.

K933364PROMED BIOPSY NEEDLEVlv Associates, Inc.K921418ULTRA-CORE BIOPSY NEEDLESMedical Device Technologies, Inc.K913815AUTOMATED BIOPSY DEVICE, MODIFICATIONHart Enterprises, Inc.K890925MANAN BONE MARROW BIOPSY NEEDLEManan Medical Products, Inc.K885145MEDSURG GREENE NEEDLEMedsurg Industries, Inc.K885149NEEDLE INSERT FOR SOFT TISSUE BIOPSY DEVICEHart Enterprises, 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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