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FDA 510(k)

KS SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC GENERAL ENDOSPOCIC AND LAPAROSCOPIC SURGICAL PROS

K-Number: K946164 · 1995-01-18

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date1995-01-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

KS SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC GENERAL ENDOSPOCIC AND LAPAROSCOPIC SURGICAL PROS is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 1995-01-18 under 510(k) number K946164. 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 KS SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC GENERAL ENDOSPOCIC AND LAPAROSCOPIC SURGICAL PROS?

KS SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC GENERAL ENDOSPOCIC AND LAPAROSCOPIC SURGICAL PROS is a medical device that received FDA 510(k) clearance on 1995-01-18. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K946164.

When did KS SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC GENERAL ENDOSPOCIC AND LAPAROSCOPIC SURGICAL PROS receive FDA 510(k) clearance?

KS SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC GENERAL ENDOSPOCIC AND LAPAROSCOPIC SURGICAL PROS received FDA 510(k) clearance on 1995-01-18, under 510(k) number K946164.

Who is the listed applicant for KS SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC GENERAL ENDOSPOCIC AND LAPAROSCOPIC SURGICAL PROS?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KS SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC GENERAL ENDOSPOCIC AND LAPAROSCOPIC SURGICAL PROS?

The FDA product code for KS SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC GENERAL ENDOSPOCIC AND LAPAROSCOPIC SURGICAL PROS is GCJ.

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Other records listing KARL STORZ Endoscopy-America, 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.

K252624KARL STORZ Laryngoscopes and AccessoriesK240506KARL STORZ HoldersK223885HOPKINS TelescopesK230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223520UNIDRIVE SIII SystemK223923HOPKINS Telescopes

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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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