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FDA 510(k)

ULTRACISON HARMONIC SCALPEL HS2 BLADE

K-Number: K941897 · 1994-07-01

ApplicantUltracision, Inc.
Decision Date1994-07-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRACISON HARMONIC SCALPEL HS2 BLADE is the device name listed in this FDA 510(k) record. The listed applicant is Ultracision, Inc.. It received FDA 510(k) clearance on 1994-07-01 under 510(k) number K941897. 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 ULTRACISON HARMONIC SCALPEL HS2 BLADE?

ULTRACISON HARMONIC SCALPEL HS2 BLADE is a medical device that received FDA 510(k) clearance on 1994-07-01. The listed applicant is Ultracision, Inc.. The 510(k) number is K941897.

When did ULTRACISON HARMONIC SCALPEL HS2 BLADE receive FDA 510(k) clearance?

ULTRACISON HARMONIC SCALPEL HS2 BLADE received FDA 510(k) clearance on 1994-07-01, under 510(k) number K941897.

Who is the listed applicant for ULTRACISON HARMONIC SCALPEL HS2 BLADE?

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 ULTRACISON HARMONIC SCALPEL HS2 BLADE?

The FDA product code for ULTRACISON HARMONIC SCALPEL HS2 BLADE 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 SCAPELK930352HARMONIC SCALPEL REUSABLE LAPORASCOPIC BLADE SYST.K924917HARMONIC 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: GEI)

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.

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

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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