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FDA 510(k)

HARMONIC SCALPEL REUSABLE LAPORASCOPIC BLADE SYST.

K-Number: K930352 · 1993-06-08

ApplicantUltracision, Inc.
Decision Date1993-06-08
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HARMONIC SCALPEL REUSABLE LAPORASCOPIC BLADE SYST. is the device name listed in this FDA 510(k) record. The listed applicant is Ultracision, Inc.. It received FDA 510(k) clearance on 1993-06-08 under 510(k) number K930352. 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 HARMONIC SCALPEL REUSABLE LAPORASCOPIC BLADE SYST.?

HARMONIC SCALPEL REUSABLE LAPORASCOPIC BLADE SYST. is a medical device that received FDA 510(k) clearance on 1993-06-08. The listed applicant is Ultracision, Inc.. The 510(k) number is K930352.

When did HARMONIC SCALPEL REUSABLE LAPORASCOPIC BLADE SYST. receive FDA 510(k) clearance?

HARMONIC SCALPEL REUSABLE LAPORASCOPIC BLADE SYST. received FDA 510(k) clearance on 1993-06-08, under 510(k) number K930352.

Who is the listed applicant for HARMONIC SCALPEL REUSABLE LAPORASCOPIC BLADE SYST.?

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

What is the FDA product code for HARMONIC SCALPEL REUSABLE LAPORASCOPIC BLADE SYST.?

The FDA product code for HARMONIC SCALPEL REUSABLE LAPORASCOPIC BLADE SYST. is GCJ.

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Other records listing Ultracision, 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.

K952726ULTRACISION HARMONIC SCAPELK941897ULTRACISON HARMONIC SCALPEL HS2 BLADEK924917HARMONIC SCALPEL 5MM LAPAROSONIC BLADE ACCESSORYK925699HARMONIC SCALPEL LAPAROSONIC CLAMP COAGULATOR ACC.K924281HARMONIC SCALPEL LAPAROSONIC BLADE ACCESSORYK911341HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO

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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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