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FDA 510(k)

LAPAROSCOPIC RETRACTOR SYSTEM

K-Number: K921006 · 1992-07-28

ApplicantLaparomed Corp.
Decision Date1992-07-28
Product CodeGCS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPIC RETRACTOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Laparomed Corp.. It received FDA 510(k) clearance on 1992-07-28 under 510(k) number K921006. The device is classified under product code GCS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROSCOPIC RETRACTOR SYSTEM?

LAPAROSCOPIC RETRACTOR SYSTEM is a medical device that received FDA 510(k) clearance on 1992-07-28. The listed applicant is Laparomed Corp.. The 510(k) number is K921006.

When did LAPAROSCOPIC RETRACTOR SYSTEM receive FDA 510(k) clearance?

LAPAROSCOPIC RETRACTOR SYSTEM received FDA 510(k) clearance on 1992-07-28, under 510(k) number K921006.

Who is the listed applicant for LAPAROSCOPIC RETRACTOR SYSTEM?

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

What is the FDA product code for LAPAROSCOPIC RETRACTOR SYSTEM?

The FDA product code for LAPAROSCOPIC RETRACTOR SYSTEM is GCS.

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 Laparomed Corp. 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.

K934527FASCIA STITCHERK930569LAPAROMED LAPAROSCOPIC RETRACTOR SYSTEMK921921CATHETER CHOLANGIOGRAPHYK921053LAPAROMED LIGATING LOOPK914066ELECTROSURGICAL CUTTING/COAGULATION DEVICE/ACCESSK910074LAPAROMED HOOK/SPATULA DEVICE

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Related Devices (Code: GCS)

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.

K944062LAPRASCOPIC GRASPERInstrument Makar, Inc.K944067PEANUT WAND, MODIFICATIONIdeal Medical, Inc.K933201AESCULAP TROCAR INSTRUMENT SETAesculap, Inc.K93276210.0MM SUCTION/IRRIGATION PROBE & TUBING KITInman Medical Corp.K933371IMC ENDOSCOPIC INSTRUMENT HOLDERInman Medical Corp.K924134LEISEGANG LAPAROSCOPIC IRRIGATION SYSTEM/ACCESSLeisegang Medical, 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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