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FDA 510(k)

LAPAROSCOPIC BALLOON RETRACTOR

K-Number: K931649 · 1993-08-06

ApplicantCabot Medical Corp.
Decision Date1993-08-06
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPIC BALLOON RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Cabot Medical Corp.. It received FDA 510(k) clearance on 1993-08-06 under 510(k) number K931649. 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 LAPAROSCOPIC BALLOON RETRACTOR?

LAPAROSCOPIC BALLOON RETRACTOR is a medical device that received FDA 510(k) clearance on 1993-08-06. The listed applicant is Cabot Medical Corp.. The 510(k) number is K931649.

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

LAPAROSCOPIC BALLOON RETRACTOR received FDA 510(k) clearance on 1993-08-06, under 510(k) number K931649.

Who is the listed applicant for LAPAROSCOPIC BALLOON RETRACTOR?

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

What is the FDA product code for LAPAROSCOPIC BALLOON RETRACTOR?

The FDA product code for LAPAROSCOPIC BALLOON RETRACTOR is GCJ.

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Other records listing Cabot Medical 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.

K960148CIRCON-SURGITEK CLASSIC DOUBLE PIGTAIL URETERAL STENTK946109CABOT MEDICAL REUSABLE BIPOLAR CUTTING FORCEPSK951972CABOT MEDICAL ULTRA FLOW CYSTOURETHROSCOPE SYSTEM WITH OPERATING & DIAGNOSTIC SHEATHSK951714CABOT MEDICAL-SURGITEK ULTRAGOLD PLUS SIDE-FIRING UROLOGIC LASER FIBERK941743CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMPK9341153000 ELECTRONIC INSUFFLATOR MODIFICATION

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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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