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FDA 510(k)

LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM

K-Number: K914547 · 1991-11-22

ApplicantBaxter Healthcare Corp
Decision Date1991-11-22
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1991-11-22 under 510(k) number K914547. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM?

LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM is a medical device that received FDA 510(k) clearance on 1991-11-22. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K914547.

When did LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM receive FDA 510(k) clearance?

LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM received FDA 510(k) clearance on 1991-11-22, under 510(k) number K914547.

Who is the listed applicant for LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM?

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

What is the FDA product code for LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM?

The FDA product code for LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM is GCJ.

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Other records listing Baxter Healthcare Corp as applicant

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Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.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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