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FDA 510(k)

ULTRACISION ULTRASONIC SCALPEL

K-Number: K895252 · 1989-10-31

ApplicantUltracision, Inc.
Decision Date1989-10-31
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRACISION ULTRASONIC SCALPEL is the device name listed in this FDA 510(k) record. The listed applicant is Ultracision, Inc.. It received FDA 510(k) clearance on 1989-10-31 under 510(k) number K895252. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRACISION ULTRASONIC SCALPEL?

ULTRACISION ULTRASONIC SCALPEL is a medical device that received FDA 510(k) clearance on 1989-10-31. The listed applicant is Ultracision, Inc.. The 510(k) number is K895252.

When did ULTRACISION ULTRASONIC SCALPEL receive FDA 510(k) clearance?

ULTRACISION ULTRASONIC SCALPEL received FDA 510(k) clearance on 1989-10-31, under 510(k) number K895252.

Who is the listed applicant for ULTRACISION ULTRASONIC SCALPEL?

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 ULTRACISION ULTRASONIC SCALPEL?

The FDA product code for ULTRACISION ULTRASONIC SCALPEL is GEI.

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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 BLADEK930352HARMONIC SCALPEL REUSABLE LAPORASCOPIC BLADE SYST.K924917HARMONIC SCALPEL 5MM LAPAROSONIC BLADE ACCESSORYK925699HARMONIC SCALPEL LAPAROSONIC CLAMP COAGULATOR ACC.K924281HARMONIC SCALPEL LAPAROSONIC BLADE ACCESSORY

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Related Devices (Code: GEI)

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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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